State regulators call on feds to close loophole that opened floodgates for delta-8

State regulators call on feds to close loophole that opened floodgates for delta-8
Cannabis regulators from 45 states have called on the U.S. Congress to define “hemp” as a crop grown exclusively for industrial or agricultural purposes to close loopholes that have allowed …

State regulators call on feds to close loophole that opened floodgates for delta-8 Read More »


#CBD #Hemp
https://hemptoday.net/state-regulators-call-on-feds-to-close-loophole-that-opened-floodgates-for-delta-8/
September 20, 2023 5:29 pm

PubMed: Oral Cannabidiol Treatment in Two Postmenopausal Women with Osteopenia: A Case Series

PubMed: Oral Cannabidiol Treatment in Two Postmenopausal Women with Osteopenia: A Case Series

Cannabis Cannabinoid Res. 2023 Sep;8(S1):S83-S89. doi: 10.1089/can.2023.0060.

ABSTRACT

Introduction: Cannabidiol (CBD), a nonintoxicating cannabinoid, may be involved in bone remodeling, but human studies are limited. In this case series, we explored the effects of oral CBD administration on bone turnover. Materials and Methods: Two postmenopausal women with osteopenia (T-score=-1 to -2.5) were randomized to receive 100 or 300 mg CBD daily (oral, bis in die [twice per day]) for 12 weeks. Serum markers of bone resorption (carboxyl-terminal collagen crosslinks [CTx]) and bone formation (procollagen type 1 N-terminal propeptide [P1NP], bone-specific alkaline phosphatase [BSAP], and osteocalcin [OC]); safety measures; plasma concentrations of CBD and metabolites; sleep disturbance; symptoms of depression, anxiety, and stress; and quality of life, were assessed. Results: CBD was well tolerated, with no clinically significant change in vital signs, hematology, chemistry, or urinalysis, and no adverse events reported. Reductions (% change vs. baseline) in CTx (-8.5%, -28.1%), P1NP (-9.9%, -39.5%), BSAP (-12.7%, -74.8%), and OC (-16.0%, -6.7%) were observed after 12 weeks of oral administration of 100 or 300 mg CBD daily, respectively. The two participants self-reported consuming 95.3% and 98.8% of CBD doses, respectively. CBD and select metabolites were measurable in plasma after 4 and 12 weeks of CBD treatment. No notable changes in sleep disturbance, depression, anxiety, stress, or quality of life were observed. Conclusions: CBD was well tolerated after 12 weeks of twice-daily oral administration and was associated with reduction in measured markers of bone turnover. Compliance with CBD treatment was good. Large-scale randomized clinical trials into the bone protective effects of CBD in postmenopausal women are warranted.

PMID:37721991 | DOI:10.1089/can.2023.0060

https://pubmed.ncbi.nlm.nih.gov/37721991/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230918190651&v=2.17.9.post6+86293ac September 18, 2023 10:00 am

PubMed: Nonlinear liquid-liquid chromatography: Modeling a binary mixture separation

PubMed: Nonlinear liquid-liquid chromatography: Modeling a binary mixture separation

J Chromatogr A. 2023 Sep 9;1708:464361. doi: 10.1016/j.chroma.2023.464361. Online ahead of print.

ABSTRACT

In liquid-liquid chromatography (LLC), mixture components are separated due to their different distribution between the phases of a biphasic liquid system composed of three or four solvents. LLC separations are typically modeled assuming that only the solutes distribute between the two liquid phases and their distribution can be described with a concentration-independent distribution constant. With increasing solute concentration, the physicochemical properties of the biphasic system change, and the distribution of the solutes becomes a function of their concentration. However, the experimental determination of liquid-liquid equilibria in multicomponent systems is time-intensive, and its prediction using thermodynamic models is often not sufficiently accurate for process design purposes. Thus, in this work, we propose a simple approach to model and simulate LLC separations in the nonlinear (concentration-dependent) range of the solutes’ distribution equilibria, namely cannabidiol (CBD) and cannabigerol (CBG). Using the inverse method, the distribution equilibrium equation parameters were estimated from pulse injection experiments of single solutes at concentrations ranging from 1 to 100 mg/mL and 1-50 mg/mL for CBD and CBG, respectively. The obtained parameters were then successfully used to predict the elution profiles of binary mixtures of different compositions at 40 mg/mL total cannabinoid concentration. The approach was demonstrated and validated for CBD and CBG as model compounds and n-hexane/methanol/water 10/7.5/2.5 (v/v/v) as the biphasic solvent system. It should be noted that the applicability of the proposed approach is system-dependent, and hence, it should be evaluated for each separation task individually.

PMID:37722348 | DOI:10.1016/j.chroma.2023.464361

https://pubmed.ncbi.nlm.nih.gov/37722348/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230919190733&v=2.17.9.post6+86293ac September 18, 2023 10:00 am

PubMed: Enhanced production of select phytocannabinoids in medical <em>Cannabis</em> cultivars using microbial consortia

PubMed: Enhanced production of select phytocannabinoids in medical <em>Cannabis</em> cultivars using microbial consortia

Front Plant Sci. 2023 Aug 31;14:1219836. doi: 10.3389/fpls.2023.1219836. eCollection 2023.

ABSTRACT

The root microbiome of medical cannabis plants has been largely unexplored due to past legal restrictions in many countries. Microbes that live on and within the tissue of Cannabis sativa L. similar to other plants, provide advantages such as stimulating plant growth, helping it absorb minerals, providing protection against pathogen attacks, and influencing the production of secondary metabolites. To gain insight into the microbial communities of C. sativa cultivars with different tetrahydrocannabinol (THC) and cannabidiol (CBD) profiles, a greenhouse trial was carried out with and without inoculants added to the growth substrate. Illumina MiSeq metabarcoding was used to analyze the root and rhizosphere microbiomes of the five cultivars. Plant biomass production showed higher levels in three of five cultivars inoculated with the arbuscular mycorrhizal fungus Rhizophagus irregularis and microbial suspension. The blossom dry weight of the cultivar THE was greater when inoculated with R. irregularis and microbial suspension than with no inoculation. Increasing plant biomass and blossom dry weight are two important parameters for producing cannabis for medical applications. In mature Cannabis, 12 phytocannabinoid compounds varied among cultivars and were affected by inoculants. Significant differences (p ≤ 0.01) in concentrations of cannabidivarinic acid (CBDVA), cannabidivarin (CBDV), cannabigerol (CBG), cannabidiol (CBD), and cannabigerolic acid (CBGA) were observed in all Cannabis cultivars when amended with F, K1, and K2 inoculants. We found microbes that were shared among cultivars. For example, Terrimicrobium sp., Actinoplanes sp., and Trichoderma reesei were shared by the cultivars ECC-EUS-THE, CCL-ECC, and EUS-THE, respectively. Actinoplanes sp. is a known species that produces phosphatase enzymes, while Trichoderma reesei is a fungal train that produces cellulase and contributes to organic matter mineralization. However, the role of Terrimicrobium sp. as an anaerobic bacterium remains unknown. This study demonstrated that the use of inoculants had an impact on the production of phytocannabinoids in five Cannabis cultivars. These inoculants could have useful applications for optimizing cannabis cultivation practices and increasing the production of phytocannabinoids.

PMID:37719209 | PMC:PMC10502174 | DOI:10.3389/fpls.2023.1219836

https://pubmed.ncbi.nlm.nih.gov/37719209/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230918190651&v=2.17.9.post6+86293ac September 18, 2023 10:00 am

PubMed: Evaluation of the Modulatory Effects of Minor Cannabinoids and Terpenes on Delta-9-Tetrahydrocannabinol Discrimination in Rats

PubMed: Evaluation of the Modulatory Effects of Minor Cannabinoids and Terpenes on Delta-9-Tetrahydrocannabinol Discrimination in Rats

Cannabis Cannabinoid Res. 2023 Sep;8(S1):S42-S50. doi: 10.1089/can.2023.0062.

ABSTRACT

Introduction: Cannabis contains a multitude of phytocannabinoids and terpenes in addition to its main psychoactive constituent, delta-9-tetrahydrocannabinol (D9-THC). It is believed that the combination of minor cannabinoids and terpenes with D9-THC may impact the subjective and physiological effects of D9-THC. In this study, select minor cannabinoids (cannabigerol [CBG], cannabidivarin [CBDV], cannabichromene [CBC], tetrahydrocannabivarin [THCV], cannabigerolic acid [CBGa], and cannabidiolic acid [CBDa]) and terpenes (beta-caryophyllene and linalool) were evaluated for their potential to decrease the interoceptive effects of D9-THC using drug discrimination methods. Materials and Methods: Male and female rats (n=16; 50% female) were trained to discriminate D9-THC from vehicle. Following training, D9-THC was administered 45 min pre-session, followed by administration of a minor cannabinoid or terpene (or vehicle) 15 min pre-session. CBG, CBDV, CBC, and THCV were administered at doses of 3-30 mg/kg; CBGa and CBDa were administered at doses of 10-100 mg/kg; beta-caryophyllene and linalool were administered at doses of 10-30 mg/kg. Percentage of D9-THC responding (%) was calculated to assess changes to D9-THCs interoceptive effects. Results: CBG, CBDV, CBC, THCV, CBGa, CBDa, beta-caryophyllene, and linalool had little effect on percent D9-THC responding in either sex. No compounds lowered percent D9-THC responding to 50% or below. THCV, CBC, CBDa, and beta-caryophyllene in combination with D9-THC decreased response rates compared with D9-THC alone. Conclusions: The minor cannabinoids and terpenes examined in the current study did not alter the discriminative stimulus effects of D9-THC. These results suggest that these compounds are unlikely to lower the psychoactive effects of D9-THC in human users.

PMID:37721992 | DOI:10.1089/can.2023.0062

https://pubmed.ncbi.nlm.nih.gov/37721992/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230918190651&v=2.17.9.post6+86293ac September 18, 2023 10:00 am

Senate to work over cannabis banking bill, but passage in House unlikely

Senate to work over cannabis banking bill, but passage in House unlikely
The U.S. Senate Banking Committee is expected to sign off a long-awaited cannabis banking bill next week that would help the hemp industry, but don’t expect any significant legislation to …

Senate to work over cannabis banking bill, but passage in House unlikely Read More »


#CBD #Hemp
https://hemptoday.net/senate-to-work-over-cannabis-banking-bill-but-passage-in-house-unlikely/
September 18, 2023 9:18 am

PubMed: Hemp Seed (<em>Cannabis sativa</em> L.) Cake as Sustainable Dietary Additive in Slow-Growing Broilers: Effects on Performance, Meat Quality, Oxidative Stability and Gut Health

PubMed: Hemp Seed (<em>Cannabis sativa</em> L.) Cake as Sustainable Dietary Additive in Slow-Growing Broilers: Effects on Performance, Meat Quality, Oxidative Stability and Gut Health

Vet Q. 2023 Sep 16:1-19. doi: 10.1080/01652176.2023.2260448. Online ahead of print.

ABSTRACT

Hemp seed cake (HSC) (Cannabis sativa L.) is a rich source of polyunsaturated fatty acids, high-quality proteins and essential amino acids. The aim of this study was to evaluate the effects of dietary inclusion of HSC on growth performance, meat quality traits, fatty acids profile and oxidative status, and intestinal morphology in slow-growing broilers. A total of 180 male slow-growing broilers were randomly assigned to one of three dietary treatments containing different levels of HSC: 0 (HSC0), 5 (HSC5) or 10% (HSC10). Birds were slaughtered at 49 days of age: breast and thigh muscles were analysed and duodenum mucosa histomorphological features were evaluated. Regardless the level of HSC inclusion, no differences among groups were found for performance and meat quality traits. The thigh and breast fatty acid profile were significantly improved in both HSC groups, with an increase of the long chain fatty acids of n-3 series and decrease of n-6/n-3 ratio. The HSC diets lowered the MDA concentration and lipid hydroperoxides in breast meat. Histomorphometrical analysis revealed a significant increase in villus height, surface area and villus/crypt ratio, with a decrease of crypt depth, suggesting that dietary supplementation with HSC may boost intestinal health status in poultry. In conclusion, dietary HSC did not affect performance, carcass traits and meat quality, while it positively influenced the lipid profile of meat, and improved the oxidative status and gut health, thus representing a valuable and sustainable alternative ingredient in broiler diet.

PMID:37715944 | DOI:10.1080/01652176.2023.2260448

https://pubmed.ncbi.nlm.nih.gov/37715944/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230917190556&v=2.17.9.post6+86293ac September 16, 2023 10:00 am

PubMed: Restoring prefrontal cortical excitation-inhibition balance with cannabidiol ameliorates neurobehavioral abnormalities in a mouse model of neurodevelopmental disorders

PubMed: Restoring prefrontal cortical excitation-inhibition balance with cannabidiol ameliorates neurobehavioral abnormalities in a mouse model of neurodevelopmental disorders

Neuropharmacology. 2023 Sep 14:109715. doi: 10.1016/j.neuropharm.2023.109715. Online ahead of print.

ABSTRACT

Maternal immune activation (MIA) resulting from viral infections during pregnancy is linked to increased rates of neurodevelopmental disorders in offspring. However, the mechanisms underlying MIA-induced neurobehavioral abnormalities remain unclear. Here, we used a poly (I:C)-induced MIA mouse model to demonstrate the presence of multiple behavioral deficits in male offspring. Through RNA sequencing (RNA-seq), we identified significant upregulation of genes involved in axonogenesis, synaptogenesis, and glutamatergic synaptic neurotransmission in the mPFC of MIA mice. Electrophysiological analyses further revealed an excitatory-inhibitory (E/I) synaptic imbalance in mPFC pyramidal neurons, leading to hyperactivity in this brain region. Cannabidiol (CBD) effectively alleviated the behavioral abnormalities observed in MIA offspring by reducing glutamatergic transmission and enhancing GABAergic neurotransmission of mPFC pyramidal neurons. Activation of GPR55 by lipid lysophosphatidylinositol (LPI), an endogenous GPR55 agonist, specifically in the mPFC of healthy animals led to MIA-associated behavioral phenotypes, which CBD could effectively reverse. Moreover, we found that a GPR55 antagonist can mimic CBD’s beneficial effects, indicating that CBD’s therapeutic effects are mediated via the LPI-GPR55 signaling pathway. Therefore, we identified mPFC as a primary node of a neural network that mediates MIA-induced behavioral abnormalities in offspring. Our work provides insights into the mechanisms underlying the developmental consequences of MIA and identifies CBD as a promising therapeutic approach to alleviate these effects.

PMID:37716533 | DOI:10.1016/j.neuropharm.2023.109715

https://pubmed.ncbi.nlm.nih.gov/37716533/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230917190556&v=2.17.9.post6+86293ac September 16, 2023 10:00 am

PubMed: Effects of CBD (Cannabidiol) on the physiology of Nile tilapia (Oreochromisn niloticus) as a chronic stress mitigating agent In-vivo

PubMed: Effects of CBD (Cannabidiol) on the physiology of Nile tilapia (Oreochromisn niloticus) as a chronic stress mitigating agent In-vivo

PLoS One. 2023 Sep 15;18(9):e0290835. doi: 10.1371/journal.pone.0290835. eCollection 2023.

ABSTRACT

This study evaluates the effects of Cannabidiol (CBD) on the physiology of stressed and non-stressed Nile tilapia, reared in a recirculating aquaculture system. Tilapia were fed with and without CBD (0.001% of feed weight) and with and without hydrocortisone stress hormone (0.01% of body weight) every day for four weeks. This experiment compared the plasma cortisol, blood glucose and protein levels, liver and spleen somatic indices (HSI and SSI, respectively), and lysozyme activity of the fish. Stress group (S) had a significantly higher value than the control group (C) in two of the parameters, glucose and lysozyme activity, this is an indication of stress. CBD had a stress reducing effect under stressed conditions in lysozyme activity. Although not significant, the stress reducing effect of CBD on stress biomarkers such as glucose and HSI also seemed promising. Further investigation into the matter may not just be useful in stress mediation in aquatic organisms but may also have implications in human medicine as well.

PMID:37713426 | DOI:10.1371/journal.pone.0290835

https://pubmed.ncbi.nlm.nih.gov/37713426/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230915190556&v=2.17.9.post6+86293ac September 15, 2023 10:00 am

PubMed: Highly selective molecularly imprinted polymer nanoparticles (MIP NPs)-based microfluidic gas sensor for tetrahydrocannabinol (THC) detection

PubMed: Highly selective molecularly imprinted polymer nanoparticles (MIP NPs)-based microfluidic gas sensor for tetrahydrocannabinol (THC) detection

Anal Chim Acta. 2023 Oct 16;1278:341749. doi: 10.1016/j.aca.2023.341749. Epub 2023 Aug 22.

ABSTRACT

A highly selective microfluidic integrated metal oxide gas sensor for THC detection is reported based on MIP nanoparticles (MIP NPs). We synthesized MIP NPs with THC recognition sites and coated them on a 3D-printed microfluidic channel surface. The sensitivity and selectivity of coated microfluidic integrated gas sensors were evaluated by exposure to THC, cannabidiol (CBD), methanol, and ethanol analytes in 300-700 ppm at 300 °C. For comparison, reference signals were obtained from a microfluidic channel coated with nonimprinted polymers (NIP NPs). The MIP and NIP NPs were characterized using scanning electron microscopy (SEM) and Raman spectroscopy. MIP and NIP NPs channels response data were combined and classified with 96.3% accuracy using the Fine KNN classification model in MATLAB R2021b Classification Learner App. Compared to the MIP NPs coated channel, the NIP NPs channel had poor selectivity towards THC, demonstrating that the THC recognition sites in the MIP structure enabled selective detection of THC. The findings demonstrated that the recognition sites of MIP NPs properly captured THC molecules, enabling the selective detection of THC compared to CBD, methanol, and ethanol.

PMID:37709477 | DOI:10.1016/j.aca.2023.341749

https://pubmed.ncbi.nlm.nih.gov/37709477/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230915190556&v=2.17.9.post6+86293ac September 14, 2023 10:00 am

PubMed: Bidimensional heart-cut achiral-chiral liquid chromatography coupled to high-resolution mass spectrometry for the separation of the main chiral phytocannabinoids and enantiomerization studies of cannabichromene and cannabichromenic acid

PubMed: Bidimensional heart-cut achiral-chiral liquid chromatography coupled to high-resolution mass spectrometry for the separation of the main chiral phytocannabinoids and enantiomerization studies of cannabichromene and cannabichromenic acid

Talanta. 2023 Sep 9;267:125161. doi: 10.1016/j.talanta.2023.125161. Online ahead of print.

ABSTRACT

In this work, a heart-cut bidimensional achiral-chiral liquid chromatography method coupled to high-resolution mass spectrometry was developed for the separation of the main carboxylated phytocannabinoids, namely cannabidiolic acid (CBDA), tetrahydrocannabinolic acid (THCA), cannabichromenic acid (CBCA), and cannabicyclolic acid (CBLA), and decarboxylated derivatives, namely cannabidiol (CBD), Δ9-tetrahydrocannabinol (Δ9-THC), cannabichromene (CBC), and cannabicyclol (CBL), and the evaluation of their enantiomeric composition in extracts of different Cannabis sativa L. varieties. Optimal conditions for the chiral analysis of CBC- and CBL-type compounds were found with methanol and water (95:5, v/v, with 0.1% formic acid, 1.5 mL/min) on an amylose-based chiral stationary phase. These settings also allowed to evaluate the parameters responsible for CBC and CBCA racemization.

PMID:37708768 | DOI:10.1016/j.talanta.2023.125161

https://pubmed.ncbi.nlm.nih.gov/37708768/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230915190556&v=2.17.9.post6+86293ac September 14, 2023 10:00 am

In another policy flip-flop, Italy again designates CBD as a narcotic

In another policy flip-flop, Italy again designates CBD as a narcotic
The Italian government has again done an about-face on CBD, issuing a new decree categorizing the hemp-derived compound as a narcotic substance. The change comes after a similar decree in …

In another policy flip-flop, Italy again designates CBD as a narcotic Read More »


#CBD #Hemp
https://hemptoday.net/in-another-policy-flip-flop-italy-again-designates-cbd-as-a-narcotic/
September 14, 2023 8:31 am

PubMed: Sex-Dependent Synergism of an Edible THC: CBD Formulation in Reducing Anxiety and Depressive-like Symptoms Following Chronic Stress

PubMed: Sex-Dependent Synergism of an Edible THC: CBD Formulation in Reducing Anxiety and Depressive-like Symptoms Following Chronic Stress

Curr Neuropharmacol. 2023 Sep 13. doi: 10.2174/1570159X21666230912101441. Online ahead of print.

ABSTRACT

Cannabis has shown therapeutic potential in mood and anxiety-related pathologies. However, the two primary constituents of cannabis, cannabidiol (CBD) and Δ-9-tetrahydrocannabinol (THC) produce distinct effects on molecular pathways in neural circuits associated with affective disorders. Moreover, it has been proposed that the combination of THC: and CBD may have unique synergistic properties. In the present study, the effects of a 1:100 THC: CBD ratio edible formulation were tested in behavioural, neuronal and molecular assays for anxiety and depressive-like endophenotypes. Adult male and female Sprague-Dawley rats were stressed for 14 days. Then, for three weeks, open field, elevated plus maze, light/dark box, social interaction, sucrose preference, and the forced swim test were performed 90 minutes after acute consumption of CBD (30 mg/kg), THC (0.3 mg/kg), or 1:100 combination of THC:CBD. After behavioural tests, in vivo, neuronal electrophysiological analyses were performed in the ventral tegmental area and prefrontal cortex (PFC). Furthermore, western-blot experiments examined the expression of biomarkers associated with mood and anxiety disorders, including protein kinase B (Akt), glycogen synthase kinase-3 (GSK-3), BDNF, mTOR, D1, and D2 receptor in nucleus accumbens (NAc) and PFC.Edible THC:CBD produces significant anxiolytic and antidepressant effects only in stressed male rats. In most cases, the combination of THC and CBD had stronger effects than either phytochemical alone. These synergistic effects are associated with alterations in Akt/GSK3 and D2-R expression in NAc and BDNF expression in PFC. Furthermore, THC:CBD reverses chronic stress-induced alterations in PFC neuronal activity. These findings demonstrate a novel synergistic potential for THC:CBD edible formulations in stress-related pathologies.

PMID:37702237 | DOI:10.2174/1570159X21666230912101441

https://pubmed.ncbi.nlm.nih.gov/37702237/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230913190639&v=2.17.9.post6+86293ac September 13, 2023 10:00 am

PubMed: Prophylactic Effects of Hemp Seed Oil on Perimenopausal Depression: A Role of HPA Axis

PubMed: Prophylactic Effects of Hemp Seed Oil on Perimenopausal Depression: A Role of HPA Axis

J Oleo Sci. 2023 Sep 12. doi: 10.5650/jos.ess23062. Online ahead of print.

ABSTRACT

Hemp seed, the dried fruit of Cannabis sativa L. (Moraceae), has been extensively documented as a folk source of food due to its nutritional and functional value. This study evaluated the antidepressant effect of hemp seed oil (HSO) during its estrogen-like effect in Perimenopausal depression (PMD) rats induced by ovariectomy combined with chronic unpredictable mild stress (OVX-CUMS). Female SD rats (SPF, 10 weeks, sham operated group, ovariectomy (OVX) model group, ovariectomy – chronic unpredictable mild stress (OVX-CUMS) group, HSO + OVX-CUMS group, fluoxetine (FLU) + OVX-CUMS group, n=8) were subjected to treatment with HSO (4.32 g/kg) or fluoxetine (10 mg/kg) for 28 days (20 mL/kg by ig). Sucrose preference test (SPT), forced swimming test (FST), open field test (OFT), estrogen receptor α (ERα) and estrogen receptor β (ERβ) expression, estradiol (E2), follicle stimulating hormone (FSH), luteinizing hormone (LH), cortisol (CORT), adrenocorticotropic hormone (ACTH), corticotropin releasing hormone (CRH), norepinephrine (NE), 5-hydroxytryptamine (5-HT) and 5-hydroxyindoleacetic acid (5HIAA) levels are measured to evaluate the function of the hypothalamic-pituitary-ovarian (HPO) and hypothalamic-pituitary-adrenal (HPA) axis. The results showed that OVX-CUMS significantly decrease sucrose preference rate in SPT, increase immobility time in FST and OFT, and decrease movement distance and stand-up times in OFT. HSO treatment significantly improves depression-like behaviors, upregulates the expression of ERα and ERβ, improves HPO axis function by increasing E2 levels and decreasing FSH and LH levels, reverses HPA axis hyperactivation by decreasing CORT, ACTH, and CRH levels, and upregulates NE, 5-HT, and 5HIAA levels in model rats. The findings suggested that HSO could improve depression-like behavior in OVX-CUMS rats by regulating HPO/HPA axis function and neurotransmitter disturbance.

PMID:37704445 | DOI:10.5650/jos.ess23062

https://pubmed.ncbi.nlm.nih.gov/37704445/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230914190550&v=2.17.9.post6+86293ac September 13, 2023 10:00 am

PubMed: Cannabidiol Inhibits the Proliferation and Invasiveness of Prostate Cancer Cells

PubMed: Cannabidiol Inhibits the Proliferation and Invasiveness of Prostate Cancer Cells

J Nat Prod. 2023 Sep 13. doi: 10.1021/acs.jnatprod.3c00363. Online ahead of print.

ABSTRACT

Prostate cancer is the fifth leading cause of cancer death in men, responsible for over 375,000 deaths in 2020. Novel therapeutic strategies are needed to improve outcomes. Cannabinoids, chemical components of the cannabis plant, are a possible solution. Preclinical evidence demonstrates that cannabinoids can modulate several cancer hallmarks of many tumor types. However, the therapeutic potential of cannabinoids in prostate cancer has not yet been fully explored. The aim of this study was to investigate the antiproliferative and anti-invasive properties of cannabidiol (CBD) in prostate cancer cells in vitro. CBD inhibited cell viability and proliferation, accompanied by reduced expression of key cell cycle proteins, specifically cyclin D3 and cyclin-dependent kinases CDK2, CDK4, and CDK1, and inhibition of AKT phosphorylation. The effects of CBD on cell viability were not blocked by cannabinoid receptor antagonists, a transient receptor potential vanilloid 1 (TRPV1) channel blocker, or an agonist of the G-protein-coupled receptor GPR55, suggesting that CBD acts independently of these targets in prostate cancer cells. Furthermore, CBD reduced the invasiveness of highly metastatic PC-3 cells and increased protein expression of E-cadherin. The ability of CBD to inhibit prostate cancer cell proliferation and invasiveness suggests that CBD may have potential as a future chemotherapeutic agent.

PMID:37703852 | DOI:10.1021/acs.jnatprod.3c00363

https://pubmed.ncbi.nlm.nih.gov/37703852/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230914190550&v=2.17.9.post6+86293ac September 13, 2023 10:00 am

PubMed: Prevalence of Δ8-tetrahydrocannabinol carboxylic acid in workplace drug testing

PubMed: Prevalence of Δ8-tetrahydrocannabinol carboxylic acid in workplace drug testing

J Anal Toxicol. 2023 Sep 12:bkad068. doi: 10.1093/jat/bkad068. Online ahead of print.

ABSTRACT

Δ8-Tetrahydrocannabinol (Δ8-THC) recently became widely available as an alternative to cannabis. Δ8-THC is likely impairing and poses a threat to workplace and traffic safety. In the present study the prevalence of Δ8-THC in workplace drug testing was investigated by analyzing 1,504 urine specimens with a positive immunoassay cannabinoid initial test using an LC-MS-MS method quantifying 15 cannabinoid analytes after hydrolysis. Δ8-tetrahydrocannabinol-9-carboxylic acid (Δ8-THC-COOH) was detected in 378 urine specimens (15 ng/mL cutoff), compared to 1,144 specimens containing Δ9-THC-COOH. The data could be divided into three general groups. There were 964 (76%) Δ9-THC-COOH dominant (<10% Δ8-THC-COOH) and 139 (11%) Δ8-THC-COOH dominant (>90% Δ8-THC-COOH) specimens, with the remaining 164 (13%) specimens showing a mixture of both analytes (>90% Δ8-THC-COOH). Similar concentrations of Δ9-THC-COOH (median 187 ng/mL) and Δ8-THC-COOH (150 ng/mL) as the dominant species support the use of similar cutoffs and decision rules for both analytes. Apart from the carboxylic acid metabolites, 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-Δ9-THC, n = 1,282), Δ9-tetrahydrocannabivarin-9-carboxylic acid (Δ9-THCV-COOH, n = 1,058), Δ9-THC (n = 746) and 7-hydroxy-cannabidiol (7-OH-CBD, n = 506) were the most prevalent analytes. Two specimens (0.13%) contained ≥140 ng/mL Δ9-THC without Δ9-THC-COOH, which could be due to genetic variability in the drug metabolizing enzyme CYP2C9 or an adulterant targeting Δ9-THC-COOH. The cannabinoid immunoassay was repeated, and five specimens (0.33%) generated negative initial tests despite Δ9-THC-COOH concentrations of 54-1,000 ng/mL, potentially indicative of adulteration. The use of Δ8-THC is widespread in the US populations, and all forensic laboratories should consider adding Δ8-THC and/or Δ8-THC-COOH to their scope of testing. Similar urinary concentrations were observed for both analytes indicating that the decision rules used for Δ9-THC-COOH are appropriate also for Δ8-THC-COOH.

PMID:37697897 | DOI:10.1093/jat/bkad068

https://pubmed.ncbi.nlm.nih.gov/37697897/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230912190602&v=2.17.9.post6+86293ac September 12, 2023 10:00 am

Symposium will hear about pre-fab building components, visit large-scale hempcrete project

Symposium will hear about pre-fab building components, visit large-scale hempcrete project
The move towards prefabricated building components is growing as interest grows in construction based on hempcrete and hemp fibers. The trend is reflected in the program of the 11th International …

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#CBD #Hemp
https://hemptoday.net/symposium-will-hear-about-pre-fab-building-components-visit-large-scale-hempcrete-project/
September 11, 2023 1:00 pm

Sustainability benefits can be lost if hemp textile production follows conventional ag

Sustainability benefits can be lost if hemp textile production follows conventional ag
While hemp production for textiles is at a “watershed moment,” hemp won’t bring promised sustainability without attention to how crops are grown, a new paper argues. “This is a material …

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https://hemptoday.net/sustainability-benefits-can-be-lost-if-hemp-textile-production-follows-conventional-ag/
September 11, 2023 8:58 am

PubMed: Dosing of Cannabinoids Associated with an Opioid-Sparing Effect: A Systematic Review of Longitudinal Studies

PubMed: Dosing of Cannabinoids Associated with an Opioid-Sparing Effect: A Systematic Review of Longitudinal Studies

Pain Manag Nurs. 2023 Sep 7:S1524-9042(23)00159-5. doi: 10.1016/j.pmn.2023.08.005. Online ahead of print.

ABSTRACT

OBJECTIVE: To assess cannabinoid dosing that could be associated with a reduction in opioid use.

DESIGN: Systematic review conducted according to the PRISMA statement.

DATA SOURCES: PubMed, Embase, Web of Science, and PsycINFO were searched up to December 10, 2022.

REVIEW/ANALYSIS METHODS: We included randomized controlled trials (RCT) and longitudinal observational studies assessing cannabinoids effect on opioid use in patients with acute or chronic pain. Two reviewers independently assessed the studies for inclusion and extracted the data. Tetrahydrocannabinol (THC), Cannabidiol (CBD), and other cannabinoids with dosing were the exposures. Change in opioid doses and opioid discontinuation were the outcomes.

RESULTS: Fifteen studies (including seven RCTs) were included. Eight studies (six observational and two RCTs) were conducted among patients with chronic pain including three with cancer-related pain. Seven studies involved patients with acute pain (five RCTs).In chronic non-cancer pain patients, two observational studies that assessed THC and CBD in combination (average daily dose 17mg/15mg), and one that assessed a CBD-rich extract (31.4 mg/day), showed a significant reduction in opioid use. Of the three studies conducted on patients with cancer, only the observational study that assessed nabilone (average 1.7 mg/day) showed a significant reduction in opioid use. In patients with acute pain, only two observational studies that assessed dronabinol (5mg and 5-10 mg/day for four days) showed a significant reduction in opioid use.

CONCLUSION: The opioid-sparing effect of cannabinoids remains uncertain based on current evidence. However, attention could be paid to cannabinoid doses associated with opioid reduction in included observational studies.

PMID:37689509 | DOI:10.1016/j.pmn.2023.08.005

https://pubmed.ncbi.nlm.nih.gov/37689509/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230910190619&v=2.17.9.post6+86293ac September 9, 2023 10:00 am

PubMed: Informing the Cannabis Conjecture: From Life's Beginnings to Mitochondria, Membranes and the Electrome-A Review

PubMed: Informing the Cannabis Conjecture: From Life's Beginnings to Mitochondria, Membranes and the Electrome-A Review

Int J Mol Sci. 2023 Aug 22;24(17):13070. doi: 10.3390/ijms241713070.

ABSTRACT

Before the late 1980s, ideas around how the lipophilic phytocannabinoids might be working involved membranes and bioenergetics as these disciplines were “in vogue”. However, as interest in genetics and pharmacology grew, interest in mitochondria (and membranes) waned. The discovery of the cognate receptor for tetrahydrocannabinol (THC) led to the classification of the endocannabinoid system (ECS) and the conjecture that phytocannabinoids might be “working” through this system. However, the how and the “why” they might be beneficial, especially for compounds like CBD, remains unclear. Given the centrality of membranes and mitochondria in complex organisms, and their evolutionary heritage from the beginnings of life, revisiting phytocannabinoid action in this light could be enlightening. For example, life can be described as a self-organising and replicating far from equilibrium dissipating system, which is defined by the movement of charge across a membrane. Hence the building evidence, at least in animals, that THC and CBD modulate mitochondrial function could be highly informative. In this paper, we offer a unique perspective to the question, why and how do compounds like CBD potentially work as medicines in so many different conditions? The answer, we suggest, is that they can modulate membrane fluidity in a number of ways and thus dissipation and engender homeostasis, particularly under stress. To understand this, we need to embrace origins of life theories, the role of mitochondria in plants and explanations of disease and ageing from an adaptive thermodynamic perspective, as well as quantum mechanics.

PMID:37685877 | DOI:10.3390/ijms241713070

https://pubmed.ncbi.nlm.nih.gov/37685877/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230909190549&v=2.17.9.post6+86293ac September 9, 2023 10:00 am

PubMed: Influence of Enzymatically Hydrophobized Hemp Protein on Morphology and Mechanical Properties of Bio-Based Polyurethane and Epoxy Foams

PubMed: Influence of Enzymatically Hydrophobized Hemp Protein on Morphology and Mechanical Properties of Bio-Based Polyurethane and Epoxy Foams

Polymers (Basel). 2023 Aug 31;15(17):3608. doi: 10.3390/polym15173608.

ABSTRACT

Biomass fillers offer the possibility to modify the mechanical properties of foams, increasing their cost-effectiveness and reducing their carbon footprint. In this study, bio-based PU (soft, open cells for the automotive sector) and epoxy (EP, hard, closed cells for construction applications) composite foams were prepared by adding pristine and laccase-mediated lauryl gallate-hydrophobized hemp protein particles as filler (HP and HHP, respectively). The fillers were able to modify the density, the mechanical properties and the morphology of the PU and EP foams. The addition of HP filler increases the density of PU foams up to 100% and significantly increases the σ values by 40% and Emod values. On the other hand, the inclusion of the HHP as filler in PU foams mostly results in reduced density, by almost 30%, and reduced σ values in comparison with reference and HP-filled foams. Independently from filler concentration and type, the biomass increased the Emod values for all foams relative to the reference. In the case of the EP foams, the tests were only conducted for the foams filled with HHP due to the poor compatibility of HP with the EP matrix. HHP decreased the density, compressive strength and Emod values of the composites. For both foams, the fillers increased the size of the cells, while reducing the amount of open cells of PU foams and the amount of closed cells for EP foams. Finally, both types of foams filled with HHP reduced the moisture uptake by 80 and 45%, respectively, indicating the successful hydrophobization of the composites.

PMID:37688234 | DOI:10.3390/polym15173608

https://pubmed.ncbi.nlm.nih.gov/37688234/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230909190549&v=2.17.9.post6+86293ac September 9, 2023 10:00 am

PubMed: Placebo-Controlled Trial of Daily Oral Cannabidiol as Adjunctive Treatment for Cats with Chronic Gingivostomatitis

PubMed: Placebo-Controlled Trial of Daily Oral Cannabidiol as Adjunctive Treatment for Cats with Chronic Gingivostomatitis

Animals (Basel). 2023 Aug 26;13(17):2716. doi: 10.3390/ani13172716.

ABSTRACT

A placebo-controlled study evaluated the clinical efficacy and safety of a commercially available cannabidiol (CBD) oral formulation as an adjunctive treatment for pain management for feline chronic gingivostomatitis (FCGS). CBD was included in a multimodal treatment routinely performed on client-owned cats with FCGS that were submitted to dental extractions. Twenty-two cats were consecutively included in the study. The first group was treated using a fixed dosage of 4 mg per cat every 12 h for 15 consecutive days, and the second received a placebo of similar features. Treatments began 2 h before dental extractions. Pain and disease severity were assessed at days 0 and 15 using the Composite Oral Pain Scale (COPS-C/F) and the Stomatitis Disease Activity Index score (SDAI). Weight, vital and biochemistry parameters, and analgesic reinforcement needs were also registered at the same time points. In the treated cats, blood was collected after 4, 8, and 12 h to determine CBD serum concentrations using ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS/MS). After data analysis using mixed models, a significant improvement in the SDAI scores of cats medicated with CBD was found. The protocol is safe since severe adverse effects and biochemical changes were not observed during the treatment period. This study suggests that the cats benefited from this treatment.

PMID:37684980 | DOI:10.3390/ani13172716

https://pubmed.ncbi.nlm.nih.gov/37684980/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230909190549&v=2.17.9.post6+86293ac September 9, 2023 10:00 am

PubMed: The dual role of cannabidiol on monocyte-derived dendritic cell differentiation and maturation

PubMed: The dual role of cannabidiol on monocyte-derived dendritic cell differentiation and maturation

Front Immunol. 2023 Aug 22;14:1240800. doi: 10.3389/fimmu.2023.1240800. eCollection 2023.

ABSTRACT

INTRODUCTION: Extracts and compounds isolated from hemp (Cannabis sativa) are increasingly gaining popularity in the treatment of a number of diseases, with topical formulations for dermatological conditions leading the way. Phytocannabinoids such as ( )-cannabidiol, ( )-cannabinol and ( )-Δ9-tetrahydrocannabivarin (CBD, CBN, and THCV, respectively), are present in variable amounts in the plant, and have been shown to have mostly anti-inflammatory effects both in vitro and in vivo, albeit dominantly in murine models. The role of phytocannabinoids in regulating responses of dendritic cells (DCs) remains unclear.

METHODS: Our research aimed to investigate the effects of CBD, CBN, and THCV on human DCs differentiated from monocytes (moDCs). moDCs were treated with up to 10 μM of each phytocannabinoid, and their effects on viability, differentiation, and maturation were assessed both alone, and in conjunction with TLR agonists. The effects of CBD on cytokine production, T cell activation and polarization as well as the transcriptome of moDCs was also determined.

RESULTS: Phytocannabinoids did not influence the viability of moDCs up to 10 μM, and only CBD had effects on maturational markers of moDCs, and neither compound influenced LPS-induced activation at 10 μM. Since only CBD had measurable effects on moDCs, in our subsequent experiments we tested the effect only of that pCB. On moDCs differentiated in the presence of CBD subsequent activation by LPS induced a markedly different, much more tolerogenic response. CBD-treated moDCs also produced significantly more interleukin (IL)-6, TNFα and, importantly, IL-10 in response to LPS, which shows a shift toward anti-inflammatory signaling, as well as a more robust secretory response in general. To rule out the possibility that these effects of CBD are specific to TLR4 signaling, we determined the effect of CBD on TLR7/8-induced maturation as well, and saw similar, although less marked responses. CBD-treated moDCs were also less efficient at activating naïve T cells after LPS stimulation, further supporting the tolerogenic effect of this phytocannabinoid on moDCs. Reactome pathway analysis showed an inflammatory response to LPS in moDCs, and to a lesser extent to CBD as well. In contrast CBD-treated moDCs responded to LPS with a shift towards a more tolerogenic phenotype, as IL-10 signaling was the most prominently induced pathway in this group.

DISCUSSION: Our results show that CBD achieves an anti-inflammatory effect on adaptive immune responses only in the presence of an activating stimuli on moDCs by reprogramming cells during long-term treatment, and not through acute, short-term effects.

PMID:37680639 | PMC:PMC10482398 | DOI:10.3389/fimmu.2023.1240800

https://pubmed.ncbi.nlm.nih.gov/37680639/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230908190550&v=2.17.9.post6+86293ac September 8, 2023 10:00 am

PubMed: Broad-Spectrum Antiviral Effect of Cannabidiol Against Enveloped and Nonenveloped Viruses

PubMed: Broad-Spectrum Antiviral Effect of Cannabidiol Against Enveloped and Nonenveloped Viruses

Cannabis Cannabinoid Res. 2023 Sep 8. doi: 10.1089/can.2023.0103. Online ahead of print.

ABSTRACT

Introduction: Cannabidiol (CBD), the main non-psychoactive cannabinoid of the Cannabis sativa plant, is a powerful antioxidant compound that in recent years has increased interest due to causes effects in a wide range of biological functions. Zika virus (ZIKV) is a virus transmitted mainly by the Aedes aegypti mosquitoes, which causes neurological diseases, such as microcephaly and Guillain-Barre syndrome. Although the frequency of viral outbreaks has increased recently, no vaccinations or particular chemotherapeutic treatments are available for ZIKV infection. Objectives: The major aim of this study was to explore the in vitro antiviral activity of CBD against ZIKV, expanding also to other dissimilar viruses. Materials and Methods: Cell cultures were infected with enveloped and nonenveloped viruses and treated with non-cytotoxic concentrations of CBD and then, viral titers were determined. Additionally, the mechanism of action of the compound during ZIKV in vitro infections was studied. To study the possible immunomodulatory role of CBD, infected and uninfected Huh-7 cells were exposed to 10 μM CBD during 48 h and levels of interleukins 6 and 8 and interferon-beta (IFN-β) expression levels were measured. On the other hand, the effect of CBD on cellular membranes was studied. For this, an immunofluorescence assay was performed, in which cell membranes were labeled with wheat germ agglutinin. Finally, intracellular cholesterol levels were measured. Results: CBD exhibited a potent antiviral activity against all the tested viruses in different cell lines with half maximal effective concentration values (CE50) ranging from 0.87 to 8.55 μM. Regarding the immunomodulatory effect of CBD during ZIKV in vitro infections, CBD-treated cells exhibited significantly IFN-β increased levels, meanwhile, interleukins 6 and 8 were not induced. Furthermore, it was determined that CBD affects cellular membranes due to the higher fluorescence intensity that was observed in CBD-treated cells and lowers intracellular cholesterol levels, thus affecting the multiplication of ZIKV and other viruses. Conclusions: It was demonstrated that CBD inhibits structurally dissimilar viruses, suggesting that this phytochemical has broad-spectrum antiviral effect, representing a valuable alternative in emergency situations during viral outbreaks, like the one caused by severe acute respiratory syndrome coronavirus 2 in 2020.

PMID:37682578 | DOI:10.1089/can.2023.0103

https://pubmed.ncbi.nlm.nih.gov/37682578/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230908190550&v=2.17.9.post6+86293ac September 8, 2023 10:00 am

PubMed: First report of <em>Spiroplasma citri</em> associated with disease symptoms in field-grown hemp (<em>Cannabis sativa</em> L.) in the Pacific Northwest

PubMed: First report of <em>Spiroplasma citri</em> associated with disease symptoms in field-grown hemp (<em>Cannabis sativa</em> L.) in the Pacific Northwest

Plant Dis. 2023 Sep 8. doi: 10.1094/PDIS-07-23-1419-PDN. Online ahead of print.

ABSTRACT

Hemp (Cannabis sativa L.) is grown for cannabinoid oil production in Oregon. During the 2021 and 2022 growing seasons, plants with leaf curling, puckering, chlorotic mosaic, fasciation, and vein clearing were observed in disease surveys of Oregon hemp fields (Fig. 1). Symptoms were present on 1-10% of 2-4-month-old plants in fields located in Benton, Clackamas, Deschutes, Jackson, Josephine, Lane, Linn, Marion, Morrow, and Polk counties between July and September. Leaf and stem samples were collected from 38 symptomatic plants. Symptoms resembled those caused by beet leafhopper-vectored (BLH, Circulifer tenellus Baker) curtovirus or phytoplasma infection. Therefore, total nucleic acids were extracted (Dellaporta et al. 1983) from leaf material, and PCR conducted on all 38 samples to detect curtovirus coat proteins (BCTV-1/2 primers; Rondon et al. 2016) and 16S rRNA of phytoplasmas (nested primers P1/P7 followed by FU/RU; Lorenz et al. 1995). No curtoviruses or phytoplasmas were detected in any samples. Spiroplasma citri is also transmitted by BLH, so PCR was conducted with primers targeting the putative P89 adhesin gene and spiralin gene of S. citri (Yokomi et al. 2008). For all samples, PCR using P89F/R primers resulted in a 707 bp amplicon, and a 675 bp amplicon with Spiralin-f/r primers. PCR products were purified with ExoSapIT (Applied Biosystems, Waltham, MA), and two representative samples (ScH1; ScH2) were Sanger sequenced (EuroFins, Lancaster, PA) in the forward and reverse direction. Pairwise aligned P89 sequences were found to be 99 to 100% (ScH1: 633/637 bp; ScH2: 654/654 bp) identical to S. citri accession KT377386. Aligned/span>spiralin sequences were found to be 99 to 100% (ScH1: 661/664 bp; ScH2: 647/647 bp) identical to S. citri accession CP013197 in the NCBI GenBank Database. All sequences were deposited into GenBank (accession no. OQ969983, OQ992766, OQ969984, OQ969986). Frozen leaf material from one sample was used to culture S. citri according to Lee and Davis (1984). Leaf tissue was surface sterilized for 60 s in 1% NaOCl in 70% ethanol, cut into pieces in LD8 broth, and incubated for 25 min at 25˚C. The solution was passed through a 0.45um filter and incubated for 14 days at 30°C with constant shaking (150 rpm). Then, cultures were centrifuged for 2 min at 12,000 rpm to pelletize, resuspended in 100µL sterile distilled water and passed through a 0.2um filter. From this culture, 2 µL of broth was used as template for both the P89F/R and Spiralin-f/r primer sets. Amplicons were purified and sequenced as above (accession nos. OQ969982, OQ969985). Leaf tissue from both representative samples (ScH1 and ScH2) were positive for S. citri using double antibody sandwich ELISA (Agdia, Inc., Elkhart, IN) following manufacturer instructions. These results from sequencing, culturing, and ELISA testing indicate the hemp samples were infected with S. citri. To our knowledge this is the first report of disease symptoms in hemp associated with S. citri in Oregon and the Pacific Northwest. Infection by S. citri can limit yield by reducing photosynthetic capability of the plant and distortion of plant growth. Other pathogens like curtoviruses and phytoplasmas have also been detected in hemp in Oregon and the U.S. (Hu 2021; Rivedal et al. 2022), and the addition of S. citri associated with disease symptoms indicates a need for BLH management research. This discovery has implications for arid regions with other S. citri hosts including cruciferous plants, carrots, and tree fruit crops, all of which were grown near the sampled hemp fields in this study.

PMID:37682222 | DOI:10.1094/PDIS-07-23-1419-PDN

https://pubmed.ncbi.nlm.nih.gov/37682222/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230908190550&v=2.17.9.post6+86293ac September 8, 2023 10:00 am

How Farm-Fresh Cannabis Can Save New York’s Industry And Equity

How Farm-Fresh Cannabis Can Save New York’s Industry And Equity

In this series, we’ve explored how cannabis left its mark on Long Island (from Hempstead to the Hamptons), how the Shinnecock Nation plans to help bring medicinal and adult-use (or ‘recreational’) cannabis to Long Island residents, and how finding success with today’s legal market may have everything to do with real estate, regulations, and learning from history. The first three parts of this four-part series also frequently made reference to the fact that cannabis is,…


#CBD #Hemp

How Farm-Fresh Cannabis Can Save New York’s Industry And Equity


September 8, 2023 1:27 am

UK study shows advertising overstates CBD levels in 4 product categories

UK study shows advertising overstates CBD levels in 4 product categories
CBD products in the UK carry less of the hemp-derived compound than advertised, according to research that looked at four product categories. The study, by researchers from Loughborough University and …

UK study shows advertising overstates CBD levels in 4 product categories Read More »


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https://hemptoday.net/uk-study-shows-advertising-overstates-cbd-levels-in-4-product-categories/
September 7, 2023 6:37 am

August 2023 510(K) Clearances

August 2023 510(K) Clearances August 2023 510(K) Clearances Anonymous (not verified) Wed, 09/06/2023 – 10:00

Detailed Description
August 2023 510(K) Clearances

 510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL DECISIONS RENDERED DURING THE PERIOD August 2023   DEVICE: Maxiocel Chitosan Wound Dressing Advamedica Inc.                   510(k) NO: K212766(Traditional) ATTN: Leo  Mavely                 PHONE NO : 1 973 7187575  Harvard Square, 1 Mifflin Place, SSE DECISION MADE: 24-AUG-23 Cambridge MA  02138               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Accu-Chek Guide Solo diabetes manager blood glucose monitoring system Roche Diabetes Care GmbH          510(k) NO: K213131(Traditional) ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331  Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23 Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Accu-Chek Solo micropump system with interoperable technology Roche Diabetes Care GmbH          510(k) NO: K213134(Traditional) ATTN: Wolfgang  Handel            PHONE NO : 49 621 7598331  Sandhofer Strasse 116             SE DECISION MADE: 10-AUG-23 Mannheim  DE 68305                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MedicloseTM System Health Value Creation BV, trading 510(k) NO: K213271(Traditional) ATTN: Kim  Sondeijker             PHONE NO : 31 43 3882948  Oxfordlaan 55                     SE DECISION MADE: 31-AUG-23 Maastricht  NL 6229 EV            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MONTAGE Settable, Resorbable Hemostatic Bone Putty Orthocon, Inc.                    510(k) NO: K213418(Traditional) ATTN: Howard  Schrayer            PHONE NO : 914 3572600  1 Bridge Street, Suite 121        SE DECISION MADE: 30-AUG-23 Irvington NY  10533               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes Becton Dickinson and Company      510(k) NO: K213670(Traditional) ATTN: Katherine Kenner Lemus      PHONE NO : 801 5419274  1 Becton Drive                    SE DECISION MADE: 25-AUG-23 Franklin Lakes NJ  07417          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Alinity h-series System Abbott Laboratories               510(k) NO: K220031(Traditional) ATTN: Neha  Vatsyayan             PHONE NO : 408 3134401  4551 Great America Pkwy           SE DECISION MADE: 04-AUG-23 Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit KRONUS, Inc.                      510(k) NO: K220085(Traditional) ATTN: Delaney  Sauer              PHONE NO : 208 3774800  170 S. Seneca Springs Way Suite 10SE DECISION MADE: 24-AUG-23 Star ID  83669                    510(k) STATEMENT                                                       DEVICE: Monaghan medical filtered mouthpiece kit Monaghan Medical Corporation      510(k) NO: K220145(Traditional) ATTN: Cari J Reil                 PHONE NO : 518 5617330  153 Industrial Boulevard          SE DECISION MADE: 24-AUG-23 Plattsburgh NY  12901             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Eco Abutment, Multiunit Abutment DIO Corporation                   510(k) NO: K220253(Traditional) ATTN: Cho  Hye-won                PHONE NO : 82 51 7457836  66, Centumseo-ro                  SE DECISION MADE: 18-AUG-23 Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SQA-iO Sperm Quality Analyzer Medical Electronic Systems LTD    510(k) NO: K220828(Traditional) ATTN: Marcia  Deutsch             PHONE NO : 972 54 7708618  Alon Hatavor 20, Zone 6, Caesarea SE DECISION MADE: 07-AUG-23 Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nova HD+ Aura Wellness, LLC                510(k) NO: K220938(Traditional) ATTN: Scott  Blomberg             PHONE NO : 502 7141993  11530 Electron Drive              SE DECISION MADE: 22-AUG-23 Louisville KY  40299              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Immunoglobulin G (IgG) Beckman Coulter Laboratory Systems510(k) NO: K221114(Traditional) ATTN: Tracy  Jin                  PHONE NO : 86 512 68955129  No. 181 West Su Hong Road, Suzhou SE DECISION MADE: 02-AUG-23 Suzhou  CN 215021                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Titus Titanium Cervical by SAGICO SAGICO VA USA, LLC                510(k) NO: K221138(Traditional) ATTN: James  Gibson               PHONE NO : 813 8150613  2189 W.Busch Blvd                 SE DECISION MADE: 04-AUG-23 Tampa FL  33612                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: circul™ pro Ring BodiMetrics, LLC                  510(k) NO: K221361(Traditional) ATTN: Mark  Goettling             PHONE NO : 818 2686828  1601 N. Sepulveda Blvd, Suite 839 SE DECISION MADE: 29-AUG-23 Manhattan Beach CA  90266         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Lumbar Expandable lnterbody Spacers -Additional Indications/Implants Globus Medical Inc.               510(k) NO: K221894(Traditional) ATTN: Kelly  Baker                PHONE NO : 610 9301800  2560 General Armistead Ave.       SE DECISION MADE: 03-AUG-23 Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ID NOW COVID-19 2.0 Abbott Diagnostics Scarborough, In510(k) NO: K221925(Dual Track) ATTN: Jessica E. Stahle           PHONE NO : 207 7306353  10 Southgate Road                 SE DECISION MADE: 10-AUG-23 Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Q21 NeuroField Inc.                   510(k) NO: K221959(Traditional) ATTN: Nicholas J. Dogris          PHONE NO : 760 8724200  386 West Lane                     SE DECISION MADE: 31-AUG-23 Bishop CA  93514                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nitrile Patient Examination Gloves, Powder Free, Pink Color Shandong YINGHNG Medical Products 510(k) NO: K222103(Traditional) ATTN: Emily  Dong                 PHONE NO : 86 53 66136888  No.15 East Road, Hongrun Industry SE DECISION MADE: 24-AUG-23 Qingzhou  CN 262500               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Protective Gown AAMI Level 4 Kenpax International Limited      510(k) NO: K222128(Traditional) ATTN: Solomon  Chen               PHONE NO : 909 4387898  Flat 5, 5/F, Wing On Plaza, 62 ModSE DECISION MADE: 08-AUG-23 Hong Kong  CN 999077              510(k) STATEMENT                                                       DEVICE: HemoScreen Hematology Analyzer PixCell Medical Technologies, Ltd.510(k) NO: K222148(Traditional) ATTN: Yaara Ben Yosef             PHONE NO : 972 4 9593516  6 Hayezira St.                    SE DECISION MADE: 16-AUG-23 Yoknaem Ilit  IL 2069202          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ACR Screw System BioMaterials Korea, Inc           510(k) NO: K222245(Traditional) ATTN: Young-yeop  Kim             PHONE NO : 82 31 7904511  #329, #331, #413 150, Jojeong-daerSE DECISION MADE: 21-AUG-23 Hanam-si  KR 12930                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Atellica® CH Phencyclidine (Pcp), Atellica® CH Vancomycin (Vanc) Siemens Healthcare Diagnostics Inc510(k) NO: K222439(Traditional) ATTN: Joy  Anoop                  PHONE NO : 516 2323307___  511 Benedict Avenue               SE DECISION MADE: 08-AUG-23 Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Air Smart Extra Spirometer FeelLife Health Inc.              510(k) NO: K222443(Traditional) ATTN: May  Xiao                   PHONE NO : 0755 66867080  Room 1903, Building A, No.9 FurongSE DECISION MADE: 09-AUG-23 Shenzhen  CN 518104               510(k) STATEMENT                                                       DEVICE: Alveoair Digital Spirometer Roundworks Technologies Private Li510(k) NO: K222525(Traditional) ATTN: Prashant  Patel             PHONE NO : 91 750 7776273  Office No. B 302, Building No. B, SE DECISION MADE: 28-AUG-23 Wakad, Pune  IN 411047            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BD Kiestra IdentifA Becton, Dickinson and Company     510(k) NO: K222563(Traditional) ATTN: Laura  Stewart              PHONE NO : 410___ 5044252  7 Loveton Circle Mail Code 694    SE DECISION MADE: 31-AUG-23 Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Premier Resolution System Trinity Biotech (Primus Corporatio510(k) NO: K222635(Traditional) ATTN: Kaitlyn  Eastman            PHONE NO : 716 4837423  4231 E. 75th Terrace              SE DECISION MADE: 04-AUG-23 Kansas City MO  64132             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Oral/Enteral Syringe with ENFit connector Anhui Tiankang Medical Technology 510(k) NO: K222772(Traditional) ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106  No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23 Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Feeding Tube Anhui Tiankang Medical Technology 510(k) NO: K222773(Traditional) ATTN: Zhang  Yong                 PHONE NO : 86 1370 5505106  No. 228, Weiyi Road, Economic DeveSE DECISION MADE: 17-AUG-23 Tianchang  CN 239300              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 072 Aspiration System Q’Apel Medical, Inc.              510(k) NO: K222786(Traditional) ATTN: Kim  Ky                     PHONE NO : 510 8284757  4245 Technology Drive             SE DECISION MADE: 25-AUG-23 Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: HAVAb IgG II ABBOTT LABORATORIES               510(k) NO: K222850(Traditional) ATTN: Dominic  Tunzi              PHONE NO : 224 6683644  100 Abbott Park Road              SE DECISION MADE: 10-AUG-23 Abbott Park IL  60064             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BlueStar CGM insulin dose calculator Welldoc, Inc.                     510(k) NO: K222888(Traditional) ATTN: Ian  Cadieux                PHONE NO : 619 8940873  10221 Wincopin Circle, Ste #150   SE DECISION MADE: 11-AUG-23 Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Oneday Mini Implant System Oneday Biotech Co., Ltd.          510(k) NO: K222946(Traditional) ATTN: Jae Hyun Song               PHONE NO : 82 53 5812835  135 C Seongseodongro Dalseogu     SE DECISION MADE: 23-AUG-23 Daegu  KR 42721                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BioProtect Balloon Implant™ System BioProtect, Ltd.                  510(k) NO: K222972(Traditional) ATTN: Itay  Barnea                PHONE NO : 97 52 8677373  8 Tsor st                         SE DECISION MADE: 25-AUG-23 Tzur Yigal  IL 4486200            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs Sentienx Sdn Bhd                  510(k) NO: K222993(Traditional) ATTN: Sahrudin Shah Bin Abu Bakar PHONE NO : 60 378 903338  Lot 7, Jalan Hi-Tech 12, Zon IndusSE DECISION MADE: 18-AUG-23 Kulim  MY 09090                   510(k) STATEMENT                                                       DEVICE: Suture Anchors - HTA Headless Titanium Anchor and Zip Anchors Gm Dos Reis Industria E Comerico L510(k) NO: K223114(Traditional) ATTN: Iara  Guimaraes             PHONE NO : 55 19 37659900  Avenida Pierre Simon De La Place 6SE DECISION MADE: 02-AUG-23 Campinas  BR 13069320             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MENIX®; MENIX® DUO S.B.M. SAS (Science & Bio Material510(k) NO: K223122(Traditional) ATTN: Anne  Cospin-Latapie        PHONE NO : 33 562 422101  ZI du Monge                       SE DECISION MADE: 03-AUG-23 Lourdes  FR 65100                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Shiley™ Pediatric Oral/Nasal Endotracheal Tube with TaperGuard™ Cuff, Non DEHP (86125, 86130, 86135, 86140, 86145, 86150, 86155, 86160) Covidien                          510(k) NO: K223130(Traditional) ATTN: Anila  Tarte                PHONE NO : 978 4966694  6135 Gunbarrel Avenue             SE DECISION MADE: 30-AUG-23 Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VisiRad XR Imidex Inc.                       510(k) NO: K223133(Traditional) ATTN: Kris  Zeschin               PHONE NO : 303 9022171___  3513 Brighton Blvd., Suites 456 7 SE DECISION MADE: 03-AUG-23 Denver CO  80216                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: APS Metal Plate & Screw System A Plus Biotechnology Co., Ltd     510(k) NO: K223150(Traditional) ATTN: Frank  Hsu                  PHONE NO : 886 2 22499222 710 2F-2, No. 120, Qiaohe Rd., ZhongheSE DECISION MADE: 24-AUG-23 New Taipei City  TW 23584         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sleepiz One+ Sleepiz AG                        510(k) NO: K223163(Third Party - Traditional) ATTN: Marta  Stepien              PHONE NO : 41 76 7837350___  Hornbachstrasse 23                SE DECISION MADE: 18-AUG-23 Zurich  CH 8008                   510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: Spirair Nasal Septal Strap Spirair, Inc.                     510(k) NO: K223167(Traditional) ATTN: James  Kintzing             PHONE NO : 703 9999462  6084 Monterey Hwy, 108            SE DECISION MADE: 17-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AIRAscore AIRAmed GmbH                      510(k) NO: K223180(Traditional) ATTN: Maximilian  Stalter         PHONE NO : 49 7071 5393366  Konrad-Adenauer-Str. 13           SE DECISION MADE: 25-AUG-23 Tübingen  DE 72072                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Spinery™ RF Ablation System Axon Spine Medical System         510(k) NO: K223303(Traditional) ATTN: Salvatore  Accardo          PHONE NO : 39 335 5300347  Via Lepanto 84                    SE DECISION MADE: 30-AUG-23 Pompei  IT 80045                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ochsner Connected Inhaler Sensor Ochsner Clinic Foundation         510(k) NO: K223367(Traditional) ATTN: Hakm  Murad                 PHONE NO : 504 8427785  1514 Jefferson Hwy                SE DECISION MADE: 30-AUG-23 New Orleans LA  70121             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Citric Complete Liquid Citric Acid Concentrate Nipro Renal Solutions USA, Corp.  510(k) NO: K223431(Traditional) ATTN: Vincent  DeGrandchamp       PHONE NO : 267 6784390  509 Fishing Creek Road            SE DECISION MADE: 04-AUG-23 Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ArtiFascia Nurami Medical Ltd.               510(k) NO: K223445(Traditional) ATTN: Hannoch  Marksheid          PHONE NO : 972 74 7408822  Ha'Namal 36                       SE DECISION MADE: 10-AUG-23 Haifa  IL 3303203                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Otsuka Digital Feedback Device-RW Otsuka America Pharmaceutical, Inc510(k) NO: K223463(Traditional) ATTN: Nancy  Teague               PHONE NO : 240 6833560___  2440 Research Boulevard           SE DECISION MADE: 11-AUG-23 Rockville MD  20850               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Nexis® compressive screws Novastep                          510(k) NO: K223468(Abbreviated) ATTN: Gilles  Audic               PHONE NO : 33 29 9338650  2, allée Jacques Frimot           SE DECISION MADE: 30-AUG-23 Rennes  FR 350000                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: V-PRO maX 2 Low Temperature Sterilization System Steris Corporation                510(k) NO: K223476(Traditional) ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437___  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AQUAbase nX, AQUAbase nX HT B. Braun Medical Inc.             510(k) NO: K223479(Traditional) ATTN: Rushtin  Chaklader          PHONE NO : 610 5962789  901 Marcon Blvd                   SE DECISION MADE: 16-AUG-23 Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SuperBall Meniscal Repair System Arcuro Medical Ltd.               510(k) NO: K223500(Traditional) ATTN: Lee  Ranon                  PHONE NO : 972 72 2607000  17 Tchelet St.                    SE DECISION MADE: 10-AUG-23 Misgav  IL 2017400                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE) Good Doctors Co., Ltd.            510(k) NO: K223507(Traditional) ATTN: Heeseop  Lim                PHONE NO : 714 2025789  #208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 04-AUG-23 Incheon  KR 21315                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Carex Hybrid Personal Lubricant Karex Industries Sdn. Bhd.        510(k) NO: K223519(Abbreviated) ATTN: Lai Peng Lim                PHONE NO : 60 7 6881996  PTD 7906 & 7907, Taman Pontian JaySE DECISION MADE: 11-AUG-23 Pontian  MY 82000                 510(k) STATEMENT                                                       DEVICE: ALLEVYN Ag+ Border Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Border Sacrum Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing, ALLEVYN Ag+ Surgical Antimicrobial Silicone Gel Adhesive Composite Hydrocellular Foam Dressing Smith & Nephew Medical Limited    510(k) NO: K223526(Traditional) ATTN: Hannah  Sharp               PHONE NO : 44 077 40531714  101 Hessle Road                   SE DECISION MADE: 18-AUG-23 Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Little Wave Clik, Rogue XP, Little Wave XP, Spark Ki Mobility LLC                   510(k) NO: K223527(Traditional) ATTN: Mark  Murphy                PHONE NO : 715 3036447  5201 Woodward Drive               SE DECISION MADE: 31-AUG-23 Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Little Wave Arc; Little Wave Flip Ki Mobility LLC                   510(k) NO: K223533(Traditional) ATTN: Mark  Murphy                PHONE NO : 715 3036447 ______ 5201 Woodward Drive               SE DECISION MADE: 31-AUG-23 Stevens Point WI  54481           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Integrity Implant Anika Therapeutics, Inc.          510(k) NO: K223538(Traditional) ATTN: Wei  Zhao                   PHONE NO : 978 8885948  32 Wiggins Ave.                   SE DECISION MADE: 17-AUG-23 Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dreem 3S Beacon Biosignals, Inc.           510(k) NO: K223539(Traditional) ATTN: Delphine  Lemoine           PHONE NO : 33 6 32047992  22 Boston Wharf Rd., 7th Floor, unSE DECISION MADE: 18-AUG-23 Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TubaVent Balloon Dilatation System Spiggle & Theis Medizintechnik Gmb510(k) NO: K223542(Traditional) ATTN: Claudia  Winterschladen     PHONE NO : 49 2206 908165  Burghof 4                         SE DECISION MADE: 03-AUG-23 Overath  DE 51491                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Water for Inhalation in 1L Flexoval ® bottles. Hometa Inc                        510(k) NO: K223551(Traditional) ATTN: Raza  Mohammed              PHONE NO : 443 5545486  300 Great Oaks Blvd, Suite 325    SE DECISION MADE: 03-AUG-23 Albany NY  12203                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine Brainlab AG                       510(k) NO: K223553(Traditional) ATTN: Sadwini  Suresh             PHONE NO : 49 8999 15680  Olof-Palme-Str.9                  SE DECISION MADE: 02-AUG-23 Munich  DE 81829                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Plato 17 Microcatheter Scientia Vascular Inc             510(k) NO: K223560(Traditional) ATTN: Max  Alfonso                PHONE NO : 888 3859016  3487 West 2100 South Suite 100    SE DECISION MADE: 21-AUG-23 West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Onera Sleep Test System (Onera STS) Onera B.V.                        510(k) NO: K223573(Traditional) ATTN: Ruben de Francisco Martin   PHONE NO : 31 0 403082177  Torenallee 42-54                  SE DECISION MADE: 18-AUG-23 Eindhoven  NL 5617BD              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: IntelliVue Patient Monitor MX400 (866060), IntelliVue Patient Monitor MX450 (866062), IntelliVue Patient Monitor MX500 (866064), IntelliVue Patient Monitor MX550 (866066) Philips Medizin Systeme Boeblingen510(k) NO: K223574(Traditional) ATTN: Siegfried  Breitling        PHONE NO : 49 151 20044377  Hewlett-Packard-Strasse 2         SE DECISION MADE: 22-AUG-23 Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pre-Filled Normal Saline Flush Syringe Anhui Tianyang Pharmaceutical Co.,510(k) NO: K223584(Traditional) ATTN: Zhang  Shunlin              PHONE NO : 86 158 05509075  46 Tiantong Road, Tianchang City, SE DECISION MADE: 12-AUG-23 Tianchang  CN                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Access Folate Assay Beckman Coulter, Inc.             510(k) NO: K223590(Traditional) ATTN: Dr. Kuljeet  Kaur           PHONE NO : 1 952 4651914___  1000 Lake Hazeline Drive          SE DECISION MADE: 23-AUG-23 Chaska MN  55318                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 23andMe® Personal Genome Service® (PGS®) Cancer Predisposition Genetic Health Risk Report for BRCA1/BRCA2 (Selected Variants) 23andMe, Inc.                     510(k) NO: K223597(Traditional) ATTN: Marianna  Frendo            PHONE NO : 650 6869288  349 Oyster Point Blvd             SE DECISION MADE: 31-AUG-23 South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterilization Wrap Wuhan Zonsen Medical Products Co.,510(k) NO: K223600(Traditional) ATTN: Linna  Ye                   PHONE NO :  No 8 Jinchao Rd, Zhucheng Street  SE DECISION MADE: 25-AUG-23 Wuhan  CN                         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LifeShield™ Infusion Safety Software Suite ICU Medical, Inc.                 510(k) NO: K223606(Traditional) ATTN: Pernell  Abrantes           PHONE NO : 224 7062229  600 N. Field Drive                SE DECISION MADE: 24-AUG-23 Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Plum Duo™ Infusion System ICU Medical, Inc.                 510(k) NO: K223607(Traditional) ATTN: Yuliya  Matlin              PHONE NO : 224 7062419  600 N. Field Drive                SE DECISION MADE: 24-AUG-23 Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: GEM Premier 7000 with IQM3 Instrumentation Laboratory Company510(k) NO: K223608(Traditional) ATTN: Gabriella  Erdosy           PHONE NO : 781 8614571  180 Hartwell Road                 SE DECISION MADE: 10-AUG-23 Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Rubicon™ Control Support Catheter (H749394323506A1) Boston Scientific Corporation     510(k) NO: K223633(Traditional) ATTN: Mary-Jo  Foley              PHONE NO : 353 0915 17427  One Scimed Place Maple Grove      SE DECISION MADE: 08-AUG-23 Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VisAble.IO TechsoMed                         510(k) NO: K223639(Traditional) ATTN: Dalia  Dickman, PhD         PHONE NO : 972 54 5595951  Meir Weisgal 2                    SE DECISION MADE: 28-AUG-23 Rehovot  IL 7654055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SaintView Inviz Corporation                 510(k) NO: K223660(Traditional) ATTN: Priscilla  Chung            PHONE NO : 714 2025789  307, Biomedical Components Center,SE DECISION MADE: 14-AUG-23 Gwangju  KR                       510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgeon Controlled Arm Levita Magnetics International Cor510(k) NO: K223673(Traditional) ATTN: Alberto  Rodriguez-Navarro, PHONE NO : 650 2410320  4055-A Campbell Avenue            SE DECISION MADE: 04-AUG-23 Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Needle Guides and Grids Advance Medical Designs, Inc.     510(k) NO: K223689(Traditional) ATTN: David  Mackie               PHONE NO : 1 770 4223125 244 1241 Atlanta Industrial Drive     SE DECISION MADE: 02-AUG-23 Marietta GA  30066                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Kyphoplasty Balloon Catheter Jiangsu Changmei Medtech Co., Ltd.510(k) NO: K223709(Traditional) ATTN: Yang  Lifan                 PHONE NO : 86 186 51969542  No.27, Xinke West Road, Luoyang ToSE DECISION MADE: 16-AUG-23 Changzhou  CN 213104              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ANNE One Sibel Health Inc.                 510(k) NO: K223711(Traditional) ATTN: Sarah  Coughlin             PHONE NO : 224 2518859  6650 W Touhy Ave.                 SE DECISION MADE: 10-AUG-23 Niles IL  60714                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free Nitrile Examination Glove (Grey) Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Better Care Plastic Technology Co.510(k) NO: K223713(Traditional) ATTN: Zhu  Chunyan                PHONE NO : 86 311 66766067  Fuqian Xi Road, West district of SSE DECISION MADE: 07-AUG-23 Shenze County  CN 050000          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Lavieen Won Tech Co., Ltd.                510(k) NO: K223727(Traditional) ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346  64 Techno 8-ro                    SE DECISION MADE: 25-AUG-23 Yuseong-gu  KR 34028              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ECGenius System Cath Vision ApS                   510(k) NO: K223787(Traditional) ATTN: Mads  Matthiesen            PHONE NO : 45 31 470730  Titangade 11                      SE DECISION MADE: 04-AUG-23 Copenhagen N  DK 2200             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Reusable Temperature Probe, Disposable Temperature Probe Shenzhen SINO-K Medical Technology510(k) NO: K223807(Traditional) ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326  Room401,Bldg2, Veteran Ind.City,GoSE DECISION MADE: 25-AUG-23 Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aveta System 2.0 Meditrina, Inc.                   510(k) NO: K223813(Traditional) ATTN: Csaba  Truckai              PHONE NO : 408 4714877  1190 Saratoga Avenue, Suite 180   SE DECISION MADE: 21-AUG-23 San Jose CA  95129                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Self-Cath Closed System Coloplast                         510(k) NO: K223821(Traditional) ATTN: Preeti  Jain                PHONE NO : 612 4135614___  1601 West River Road North        SE DECISION MADE: 02-AUG-23 Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: eRapid Nebulizer System PARI Respiratory Equipment, Inc.  510(k) NO: K223840(Traditional) ATTN: Michael  Judge              PHONE NO : 804 2537274  2412 Pari Way                     SE DECISION MADE: 11-AUG-23 Midlothian VA  23112              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NuEra Tight RF Family BIOS s.r.l.                       510(k) NO: K223856(Traditional) ATTN: Manuela  Brambilla          PHONE NO : 0039 02 27304275  Via Guido Rossa 10/12             SE DECISION MADE: 11-AUG-23 Vimodrone  IT 20055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: IDS ACTH II Immunodiagnostic Systems Limited  510(k) NO: K223867(Traditional) ATTN: Mick  Henderson             PHONE NO : 44 191___ 5190660  10 Didcot Way,  Boldon Business PaSE DECISION MADE: 18-AUG-23 Boldon  GB NE35 9PD               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BAROguard Paragonix Technologies            510(k) NO: K223874(Traditional) ATTN: Nathan  Yetton              PHONE NO : 1 617 8177790  Suite 408, 639 Granite St.        SE DECISION MADE: 15-AUG-23 Braintree MA  02184               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Daye Tampon Annes Daye Ltd                    510(k) NO: K223883(Traditional) ATTN: Valentina  Milanova         PHONE NO : 447 366 456294  The Biscuit Factory, 100 Drummond SE DECISION MADE: 18-AUG-23 London  GB SE16 4DG               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VitalFlowTM Centrifugal Pump Michigan Critical Care Consultants510(k) NO: K223898(Traditional) ATTN: Martha  Rumford             PHONE NO : 734 9959089  2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23 Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: InterCollagen® Guide SigmaGraft Inc.                   510(k) NO: K223912(Traditional) ATTN: Elcin  Chang                PHONE NO : 1 714 5250112  575 Sally Place                   SE DECISION MADE: 17-AUG-23 Fullerton CA  92831               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SOMNUM (V.1.1.2.) Honeynaps Co., Ltd                510(k) NO: K223922(Traditional) ATTN: Tony  Lee                   PHONE NO : 82 108 9220937  4F, Marine Tech B/D, 529, NonhyeonSE DECISION MADE: 16-AUG-23 Seoul  KR 06126                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LW Implant System Ossvis Co., Ltd.                  510(k) NO: K223924(Traditional) ATTN: Young Jae Kim               PHONE NO : 82 31 3600082  7F and B1, 38, Burim-ro 170beon-giSE DECISION MADE: 08-AUG-23 Anyang-si  KR 14055               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Silk'n Titan Allways Silk'n Beauty Ltd.                510(k) NO: K230013(Traditional) ATTN: Amit  Goren                 PHONE NO : 972 4 9097470  Tabor Building, Shaar Yokneam     SE DECISION MADE: 30-AUG-23 Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption Tonica Elektronik A/S             510(k) NO: K230014(Traditional) ATTN: Jan  Kjøller                PHONE NO : 45 2 4899976  Lucernemarken 15                  SE DECISION MADE: 25-AUG-23 Farum  DK DK-3520                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Dermatitis Potential Ansell Healthcare Products, LLC.  510(k) NO: K230079(Traditional) ATTN: Don  Cronk                  PHONE NO : 775 4707106  2301 Robb Drive                   SE DECISION MADE: 23-AUG-23 Reno NV  89523                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Responsive Arthroscopy Stealth and Mini Stealth All-Suture Anchors Responsive Arthroscopy LLC        510(k) NO: K230094(Traditional) ATTN: Garrett  Ahlborg            PHONE NO : 612 5326800  701 N. 3rd Street, Suite 208      SE DECISION MADE: 25-AUG-23 Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dentis s-Clean Regular Abutment Dentis Co., Ltd                   510(k) NO: K230126(Traditional) ATTN: Gyu Ri Kim                  PHONE NO : 82 53 5893541  99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 04-AUG-23 Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Mick Valencia Applicator Set Mick Radio-Nuclear Instruments, In510(k) NO: K230155(Traditional) ATTN: James  Hurlman              PHONE NO : 914 6670291  521 Homestead Avenue              SE DECISION MADE: 30-AUG-23 Mount Vernon NY  10550            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SoundBite® Crossing System XS Peripheral Soundbite Medical Solutions, Inc. 510(k) NO: K230159(Traditional) ATTN: Diane  Marceau              PHONE NO : 514 9562525 3352 2300 Alfred Nobel, Suite 230      SE DECISION MADE: 28-AUG-23 Montreal  CA H4S 2A4              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: uCT 760 with uWS-CT-Dual Energy Analysis, uCT 780 with uWS-CT-Dual Energy Analysis Shanghai United Imaging Healthcare510(k) NO: K230162(Traditional) ATTN: Xin  Gao                    PHONE NO : 86 21670 768885386  No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 01-AUG-23 Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Luja Coudé (20118 Male CH8 - small packaging (Pocket size)), Luja Coudé (20111 Male CH10 - small packaging (Pocket size)), Luja Coudé (20112 Male CH12 - small packaging (Pocket size)), Luja Coudé (20114 Male CH14 - small packaging (Pocket size)), Luja Coudé  (20101 Male CH10 - large packaging), Luja Coudé  (20102 Male CH12 - large packaging), Luja Coudé  (20104 Male CH14 - large packaging), Luja Coudé  (20106 Male CH16 - large packaging) Coloplast                         510(k) NO: K230165(Traditional) ATTN: Troy  Thome                 PHONE NO : 612 3569917  1601 West River Road North        SE DECISION MADE: 25-AUG-23 Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pulse Oximeter Beijing Choice Electronic Technolo510(k) NO: K230172(Traditional) ATTN: Haiying  Zhao               PHONE NO : 86 10 88794631  No. 9 Shuangyuan road, Badachu Hi-SE DECISION MADE: 12-AUG-23 Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy) Versant Medical Physics and Radiat510(k) NO: K230221(Traditional) ATTN: Darrell R. Fisher           PHONE NO : 509 5393223___  119 N. Church Street              SE DECISION MADE: 28-AUG-23 Kalamazoo MI  49007               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZenPro 40 Bluecore Company Co Ltd           510(k) NO: K230268(Traditional) ATTN: Bill  Choi                  PHONE NO : 82 517 474318  Ace Hightech 21 #1203 48, Centurm SE DECISION MADE: 10-AUG-23 Busan  KR 48059                   510(k) STATEMENT                                                       DEVICE: PMT Expandable Cage (PMT EXP) Providence Medical Technology, Inc510(k) NO: K230297(Traditional) ATTN: Edward  Liou                PHONE NO : 415 9239376  4234 Hacienda Drive, Suite 150    SE DECISION MADE: 11-AUG-23 Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celsi Monitor Hadleigh Health Technologies      510(k) NO: K230298(Traditional) ATTN: Molly  McCabe               PHONE NO : 510 6733653  30 Castro Avenue                  SE DECISION MADE: 16-AUG-23 San Rafael CA  94901              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polyisoprene Surgical Gloves Puyang Linshi Medical Supplies Co.510(k) NO: K230304(Traditional) ATTN: Catherine  Liu              PHONE NO : 86 198 39327898  East of Panjin Road and North of FSE DECISION MADE: 09-AUG-23 Puyang  CN 457001                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue, Black &White Colors) New Era Medicare Sdn. Bhd.        510(k) NO: K230314(Traditional) ATTN: Fatin Nor Irdina binti AhmadPHONE NO : 60 149 072860  Plot 2621-2624                    SE DECISION MADE: 16-AUG-23 Teluk Intan  MY 36000             510(k) STATEMENT                                                       DEVICE: Phototherapy System  (OL-PDT950) Shanghai Omni Laser Skinology Co.,510(k) NO: K230342(Traditional) ATTN: Avril  Ouyang               PHONE NO : 86 021 54847192  Floor 3, Building 3, NO.227, MingqSE DECISION MADE: 16-AUG-23 Shanghai  CN 201612               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR Canon Medical Systems Corporation 510(k) NO: K230355(Traditional) ATTN: Janine F Reyes              PHONE NO : 714 6697853  1385 Shimoshigami                 SE DECISION MADE: 30-AUG-23 Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VitalFlow™ Console Michigan Critical Care Consultants510(k) NO: K230364(Traditional) ATTN: Martha  Rumford             PHONE NO : 734 9959089  2555 Bishop Circle West           SE DECISION MADE: 25-AUG-23 Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Reprocessed Agilis NxT Steerable Introducer Innovative Health, LLC.           510(k) NO: K230376(Traditional) ATTN: Rick  Ferreira              PHONE NO : 877 4003740  1435 North Hayden Road, Suite 100 SE DECISION MADE: 07-AUG-23 Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgical Face Masks, Model: EFMDS-L50Pn BLU Iris USA                          510(k) NO: K230380(Traditional) ATTN: Michael  Cruz               PHONE NO : 602 7071770  11111 80th Ave.                   SE DECISION MADE: 03-AUG-23 Pleasant Prairie WI  53158        510(k) STATEMENT                                                       DEVICE: PolyWear® Personal Protective Level 3 Gown Polyconversions, INC              510(k) NO: K230384(Traditional) ATTN: William  Smith              PHONE NO : 309 6623614  3202 Apollo Drive                 SE DECISION MADE: 11-AUG-23 Champaign IL  61822               510(k) STATEMENT                                                       DEVICE: Wrist Type Blood Pressure Monitor (W05,W1101L) Shenzhen Jamr Technology Co., Ltd.510(k) NO: K230409(Traditional) ATTN: Haiyu  Zhang                PHONE NO : 86 186 75539961  A101-301, D101-201, Jamr Science &SE DECISION MADE: 25-AUG-23 Shenzhen  CN 518100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cadwell Guardian Cadwell Industries, Inc.          510(k) NO: K230415(Traditional) ATTN: Jason  Ford                 PHONE NO : 509 7356481  909 North Kellogg Street          SE DECISION MADE: 17-AUG-23 Kennewick WA  99336               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sequel Tampon with Plastic Applicator Tampro Inc                        510(k) NO: K230419(Traditional) ATTN: Greta  Meyer                PHONE NO : 215 2609081  3749 Buchanan Street #316         SE DECISION MADE: 03-AUG-23 San Fransisco CA  94123           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dr. pen Microneedling System Guangzhou Ekai Electronic Technolo510(k) NO: K230420(Traditional) ATTN: Guihua  Chen                PHONE NO : 86 020 81177539  3/F Building E No.81 Zijing Road, SE DECISION MADE: 11-AUG-23 Guangzhou  CN 510000              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ambu® aScope™ 5 Broncho 2.7/1.2, Ambu® aScope™ 5 Broncho 4.2/2.2, Ambu® aBox™ 2 Ambu A/S                          510(k) NO: K230428(Traditional) ATTN: Karina  Matthiesen          PHONE NO : 45 7225 2094  Baltorpbakken 13                  SE DECISION MADE: 10-AUG-23 Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Syringe Bulk Tray Shanghai Kindly Enterprise Develop510(k) NO: K230447(Traditional) ATTN: Hualong  Liu                PHONE NO : 86 02169 118232  No.658 Gaochao Road               SE DECISION MADE: 16-AUG-23 Shanghai  CN 201803               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cove Strip SeaSpine Orthopedics Corporation  510(k) NO: K230486(Traditional) ATTN: Cindy  Toyama               PHONE NO : 949 8557175  2 Goodyear                        SE DECISION MADE: 21-AUG-23 Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EL27-Compact; Sterile EHL-Probes Walz Elektronik GmbH              510(k) NO: K230488(Traditional) ATTN: Bernd  Vollmer              PHONE NO : 49 745 22020  Walddorfer Strasse 40             SE DECISION MADE: 31-AUG-23 Rohrdorf  DE 72229                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Visual-ICE Cryoablation System Boston Scientific Corporation     510(k) NO: K230551(Traditional) ATTN: Amy  McKinney               PHONE NO : 651 2875096  One Scimed Place                  SE DECISION MADE: 08-AUG-23 Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure Monitor Joytech Healthcare Co.,Ltd        510(k) NO: K230566(Traditional) ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767  No.365, Wuzhou Road Yuhang EconomiSE DECISION MADE: 25-AUG-23 Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) Medcare Saglik Urunleri Sanayi Ve 510(k) NO: K230577(Traditional) ATTN: Muge  Ersahin               PHONE NO : 90 232 28116  Fatih Mah. Camlik Cad No 54       SE DECISION MADE: 16-AUG-23 Izmir  TR 35410                   510(k) STATEMENT                                                       DEVICE: Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl WRP Asia Pacific Sdn. Bhd.        510(k) NO: K230578(Traditional) ATTN: Saravanan  Ramasamy         PHONE NO : 60 387 061486  Lot 1, Jalan 3, Kawasan PerusahaanSE DECISION MADE: 31-AUG-23 Sepang  MY 43900                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Smart Wedge algorithm Edwards Lifesciences, LLC         510(k) NO: K230579(Traditional) ATTN: Jennifer  Wilbur            PHONE NO : 949 7564436  1 Edwards Way                     SE DECISION MADE: 18-AUG-23 Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TOPA12 Portable X-ray Unit NEUF Inc.                         510(k) NO: K230581(Traditional) ATTN: Woo Sang Lee                PHONE NO : 82 61 7402830  #103 Production Bldg. 13, YulchonsSE DECISION MADE: 16-AUG-23 Suncheon-si  KR 58034             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aer-O-Scope Colonoscope System GI View Ltd.                      510(k) NO: K230588(Traditional) ATTN: Sharon  Goldfarb            PHONE NO : 972 54 6454034  5 Shoham St.                      SE DECISION MADE: 17-AUG-23 Ramat Gan  IL 5251001             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arrow Non-Stimulating SnapLock Adapter (K-05520-005C); Arrow Non-Stimulating Next Gen SnapLock Adapter (Luer Connection) (CA-000010-19); Arrow Non-Stimulating Next Gen SnapLock Adapter (Neuraxial Connection) (CA-000014-19); Arrow Stimulating SnapLock Adapter (with cable) (TZ-02060-001); Arrow Stimulating SnapLock Adapter (with tab) (TZ-05000-002) Teleflex Medical                  510(k) NO: K230603(Traditional) ATTN: Kristen  Bisanz             PHONE NO : 404 2909807  3015 Carrington Mill Blvd.        SE DECISION MADE: 30-AUG-23 Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPICCA Cervical Fusion Cages Southern Medical (Pty) Ltd        510(k) NO: K230607(Traditional) ATTN: Nathan  Wright              PHONE NO : 719 3510248  Building 10, Southern Implants OffSE DECISION MADE: 14-AUG-23 Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPICCA Stand-Alone Cervical Fusion Cages Southern Medical (Pty) Ltd        510(k) NO: K230608(Traditional) ATTN: Dalene  Styger              PHONE NO : 27 12 6676243  55 Regency Drive Route 21 CorporatSE DECISION MADE: 14-AUG-23 Irene  ZA 0178                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) Dongguan Shin Yi Healthcare Produc510(k) NO: K230610(Traditional) ATTN: Shuge  Zhao                 PHONE NO : 86 769 8336138  No. 17 Ban Hu Road, Huang Jiang ToSE DECISION MADE: 23-AUG-23 Dong Guan  CN 523750              510(k) STATEMENT                                                       DEVICE: SKEEPER Smartsound Corporation            510(k) NO: K230613(Traditional) ATTN: Jungho  Lee                 PHONE NO : 82 257 52252  171, Yangjaecheon-ro, Gangnam-gu  SE DECISION MADE: 02-AUG-23 Seoul  KR 06302                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter Gentuity, LLC                     510(k) NO: K230620(Traditional) ATTN: Padmini  Gagnon             PHONE NO : 508 4251560  142 North Road, Suite G           SE DECISION MADE: 08-AUG-23 Sudbury MA  01776                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ReliOn Premier BLU Blood Glucose Monitoring System i-SENS, Inc.                      510(k) NO: K230625(Special) ATTN: H.S.  Yoo                   PHONE NO : 82 29 100516  43, Banpo-Daero 28 Gil Seocho-Gu  SE DECISION MADE: 10-AUG-23 Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Portrait™ Central Viewer Application (Portrait CV A01), Portrait ™ Core Services (Portrait CSS01), Portrait™ Clinical Alarming Unit (Portrait CAU01); Portrait™ Mobile Patient Monitor (Portrait HUB01), Portrait™ Sensor Battery (Portrait SBT01), Portrait™ Bedside Charger (Portrait BCH01); Portrait™ Wearable Pulse Oximetry Sensor (Portrait SpO2 P-SA01, Portrait SpO2 P-SP01, Portrait SpO2 P-W01 and Portrait SpO2 P-SE01); Portrait™ SpO2 Attachment Accessory Band (Portrait AAB01), Portrait™ Mobile Patient Monitor Pouch (Portrait MMP01); Portrait™ Wearable Respiration Rate Sensor (Portrait RR P-RR01), Portrait™ RR Electrode Patch (Portrait RRP01) GE Medical Systems Information Tec510(k) NO: K230626(Traditional) ATTN: Joel  Kent                  PHONE NO : 617 8510943  9900 Innovation Drive             SE DECISION MADE: 11-AUG-23 Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VersiHD with GuideMe software NxStage Medical, Inc.             510(k) NO: K230632(Traditional) ATTN: Denise  Oppermann           PHONE NO : 781 9969103  350 Merrimack St.                 SE DECISION MADE: 11-AUG-23 Lawrence MA  01843                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electronic Blood Pressure Monitor Dongguan kangweile Electronic Tech510(k) NO: K230642(Traditional) ATTN: Zhixin  Gao                 PHONE NO : 86 769 82677482  4th floor, building D, Yizhong SciSE DECISION MADE: 11-AUG-23 Dongguan  CN 523770               510(k) STATEMENT                                                       DEVICE: Density Jeisys Medical Inc.               510(k) NO: K230663(Traditional) ATTN: Bora  Kim                   PHONE NO : 82 10 30197221  307 Daeryung Techno Town 8th      SE DECISION MADE: 14-AUG-23 Seoul  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Annabella Breast Pump Annabella Ltd.                    510(k) NO: K230672(Traditional) ATTN: Uri  Yaffe                  PHONE NO : 97 254 5555484  23/5 Hataas                       SE DECISION MADE: 04-AUG-23 KFAR SABA  IL 4442525             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Tandry Locking Plate System Microware Precision Co., Ltd.     510(k) NO: K230690(Traditional) ATTN: Harrison  Du                PHONE NO : 886 4 24636275 100 No. 12, Keyuan 2nd Rd., Situn DistSE DECISION MADE: 17-AUG-23 Taichung  TW 40763                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG   510(k) NO: K230733(Traditional) ATTN: Gregory  Gohl               PHONE NO : 269 3701476  Boetzinger Strasse 41             SE DECISION MADE: 05-AUG-23 Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Disposable Ureteral Access Sheath YouCare Technology Co., Ltd. (Wuha510(k) NO: K230748(Traditional) ATTN: Bing  Hu                    PHONE NO : 86 27 87926396 830___ Tangxunhu North Street            SE DECISION MADE: 02-AUG-23 Wuhan  CN 430000                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TK Pre-Filled Normal Saline Flush Syringe Anhui Tiankang Medical Technology 510(k) NO: K230756(Traditional) ATTN: Bai  Baodong                PHONE NO : 86 1350 5557811  No. 228 Weiyi Road, Economic DevelSE DECISION MADE: 12-AUG-23 Tianchang  CN                     510(k) STATEMENT                                                       DEVICE: Precice Ankle Salvage System NuVasive Specialized Orthopedics, 510(k) NO: K230765(Traditional) ATTN: Miriam  Cervantes           PHONE NO : 909 2297836  101 Enterprise, Suite 100         SE DECISION MADE: 29-AUG-23 Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Withings Scan Monitor 2.0 Withings                          510(k) NO: K230812(Traditional) ATTN: Khushboo  Surendran         PHONE NO : 857 2052072  2 rue Maurice Hartmann            SE DECISION MADE: 23-AUG-23 Issy-Les-Moulineaux  FR 92130     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powdered Free Sterile Natural Rubber Latex Surgical Gloves The Egyptian Company For Medical &510(k) NO: K230832(Traditional) ATTN: Alaa  Elsayed               PHONE NO : 201 0000 80163  Industrial Zone 7. Part 7062A&B   SE DECISION MADE: 16-AUG-23 Sadat City  EG                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EXTRON 5; EXTRON 7 DRTECH Corporation                510(k) NO: K230871(Traditional) ATTN: Kim  Minjeong               PHONE NO : 82 031 7797783  Suite No. 1, 2 Floor/Suite No. 2, SE DECISION MADE: 17-AUG-23 Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments Southern Implants (Pty) Ltd       510(k) NO: K230873(Traditional) ATTN: Colin  Saffy                PHONE NO : 27 12 6671046  1 Albert Road                     SE DECISION MADE: 01-AUG-23 Irene  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: qXR-PTX-PE Qure.ai Technologies              510(k) NO: K230899(Traditional) ATTN: Ayushi  Mahendra            PHONE NO : 91 22 68505800  Level 7, Commerz II, InternationalSE DECISION MADE: 22-AUG-23 Mumbai  IN 400063                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter Vein 360 LLC                      510(k) NO: K230928(Traditional) ATTN: Suzanne  Meyer              PHONE NO : 513 5541300  4460 Lake Forest Dr Suite 230     SE DECISION MADE: 25-AUG-23 Blue Ash OH  452423741            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arthrex Radiopaque FiberTape Cerclage sutures Arthrex, Inc                      510(k) NO: K230976(Traditional) ATTN: Stacy  Valdez               PHONE NO : 1 239 6435553 72010 1370 Creekside Boulevard          SE DECISION MADE: 24-AUG-23 Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Yomi Robotic System Neocis Inc.                       510(k) NO: K231018(Traditional) ATTN: Joshua  Davis               PHONE NO : 508 2940749  2800 Biscayne Blvd Suite 600      SE DECISION MADE: 14-AUG-23 Miami FL  33137                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AquaBeam Robotic System PROCEPT BioRobotics Corporation   510(k) NO: K231024(Traditional) ATTN: Sara  Muddell               PHONE NO : 650 2327217  900 Island Drive, Suite 101       SE DECISION MADE: 30-AUG-23 Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 12MP Color LCD Monitor C1216W, C12*** ("*" = 0 to 9, A to Z or blank, and the difference among models means the product is named according to different appearance colors and customer models) Shenzhen Beacon Display Technology510(k) NO: K231026(Traditional) ATTN: Li  Yafei                   PHONE NO : 86 248 8087610  15F, Building 6, Hengda Shishang HSE DECISION MADE: 18-AUG-23 Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Unicare (K-UNICARE-USA) TensCare Ltd                      510(k) NO: K231053(Traditional) ATTN: Saskia  Eldridge-Hinmers    PHONE NO : 44 137 2723434  9 Blenheim Road                   SE DECISION MADE: 18-AUG-23 Epsom  GB KT199BE                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: V-Laser WON TECH Co., Ltd.                510(k) NO: K231054(Special) ATTN: Hyun Sik Yoon               PHONE NO : 82 10 67505346  64 Techno 8-ro, Yuseong-gu        SE DECISION MADE: 14-AUG-23 Daejeon  KR 34028                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 1.5T HD T/R Knee Array (10-F34127) Shenzhen RF Tech Co., Ltd.        510(k) NO: K231085(Traditional) ATTN: Wang  Gary                  PHONE NO : 0086__ 7552 6641989  2-F,BLD4 Juhui Industrial Park,TiaSE DECISION MADE: 18-AUG-23 Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Guided Surgery Kit Implant Direct Sybron Manufacturin510(k) NO: K231087(Traditional) ATTN: Reina  Choi                 PHONE NO : 1 818 3073132  3050 East Hillcrest Drive         SE DECISION MADE: 16-AUG-23 Thousand Oaks CA  91362           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AlphaVent Suture Anchors Stryker Endoscopy                 510(k) NO: K231093(Traditional) ATTN: Katie  Farraro              PHONE NO : 408___ 4647396  5900 Optical Ct.                  SE DECISION MADE: 30-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Annalise Enterprise CTB Triage-OH Annalise-AI Pty Ltd               510(k) NO: K231094(Traditional) ATTN: Haylee  Bosshard            PHONE NO : 61 4932 66602  Level P, 24 Campbell St.          SE DECISION MADE: 15-AUG-23 Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Automatic Continuous Effusion Shunt (ACES) System ACES System Pleural Dynamics, Inc.            510(k) NO: K231096(Traditional) ATTN: Martin  Mayse               PHONE NO : 314 5181786  952 Medina Road                   SE DECISION MADE: 18-AUG-23 Wayzata MN  55391                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LineSider® Spinal System Integrity Implants Inc.           510(k) NO: K231098(Traditional) ATTN: Alexa  Kamer                PHONE NO : 561 5293861  354 Hiatt Drive                   SE DECISION MADE: 07-AUG-23 Palm Beach Gardens FL  33418      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail System Zimmer Switzerland Manufacturing G510(k) NO: K231114(Traditional) ATTN: Annemie Kausch Rehor        PHONE NO : 41 795 615986  Sulzerallee 8                     SE DECISION MADE: 09-AUG-23 Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) Phoenix Innovative Healthcare Manu510(k) NO: K231123(Traditional) ATTN: Michael  Stuart             PHONE NO : 954 8804274  EL-209, Shil Mahape Road ElectroniSE DECISION MADE: 30-AUG-23 Navi Mumbai  IN 400710            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Eblator Device E Surgical, LLC                   510(k) NO: K231126(Traditional) ATTN: Michael  Blomeyer           PHONE NO : 775___ 4331808___  150 Isidor Court Unit 203         SE DECISION MADE: 02-AUG-23 Sparks NV  89441                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Enzyme Packed Cartridge - RELiZORB Alcresta Therapeutics, Inc.       510(k) NO: K231156(Traditional) ATTN: Matthew  King               PHONE NO : 603 4599755  130 Turner Street, Building 3, SuiSE DECISION MADE: 30-AUG-23 Waltham MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Conductive carbon film electrode Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231164(Traditional) ATTN: Sammy  Li                   PHONE NO : 86 020 34822409  No.23 Building, The Second Phase, SE DECISION MADE: 09-AUG-23 Guangzhou  CN 511450              510(k) STATEMENT                                                       DEVICE: Conductive Silicone Rubber Electrode Guangzhou Xinbo Electronic Co., Lt510(k) NO: K231167(Traditional) ATTN: Sammy  Li                   PHONE NO : 86 020 34822409  No.23 Building, The Second Phase HSE DECISION MADE: 09-AUG-23 Guangzhou  CN 511450              510(k) STATEMENT                                                       DEVICE: BPBIO750 InBody Co, Ltd.                   510(k) NO: K231174(Traditional) ATTN: Kichul  Cha                 PHONE NO : 82 02 5013939  15, Heugam-Gil , Ipjang-Myueon, SeSE DECISION MADE: 02-AUG-23 Cheonan-Si  KR 31025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Non absorbable Surgical Polyester Suture Shandong Haidike Medical Products 510(k) NO: K231183(Traditional) ATTN: Yan  Wang                   PHONE NO : 86 530 4660062  Tianfu Road, Dongcheng District, SSE DECISION MADE: 25-AUG-23 Heze  CN 274300                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Cochlear™ Osia® System; Cochlear™ Osia® OSI300 Implant; Cochlear™ Magnet Cassette; Cochlear™ Non-Magnetic Cassette; Cochlear™ Osia® 2(I) Sound Processor; Cochlear™ Osia® Fitting Software 2; Cochlear™ Osia® Smart App Cochlear                          510(k) NO: K231204(Traditional) ATTN: Denis  DiMartino            PHONE NO : 508 3044356  10350 Park Meadows Drive          SE DECISION MADE: 18-AUG-23 Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray GuruNanda LLC                     510(k) NO: K231205(Traditional) ATTN: Puneet  Nanda               PHONE NO : 714 4100466  6645 Caballero Blvd.              SE DECISION MADE: 22-AUG-23 Buena Park CA  90620              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker Resorbable Fixation System Stryker Leibinger GmbH & Co. KG   510(k) NO: K231208(Traditional) ATTN: Gregory  Gohl               PHONE NO : 269 3701476  Boetzinger Strasse 41 D-79111     SE DECISION MADE: 14-AUG-23 Freiburg  DE                      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ventrax™ Delivery System  (VTR851) Merit Medical Systems, Inc.       510(k) NO: K231246(Traditional) ATTN: Jenny  Soderquist           PHONE NO : 801 2084579  1600 West Merit Parkway           SE DECISION MADE: 30-AUG-23 South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NovoFine® Plus Novo Nordisk Inc.                 510(k) NO: K231255(Special) ATTN: Hiral Palkhiwala Shah       PHONE NO : 609 7877603  P.O Box 846                       SE DECISION MADE: 25-AUG-23 Plainsboro NJ  08536              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pangea Utility Plating System, Pangea Platform Stryker GmbH                      510(k) NO: K231257(Traditional) ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452  325 Corporate Drive               SE DECISION MADE: 18-AUG-23 Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System Stryker GmbH                      510(k) NO: K231262(Traditional) ATTN: Danese  Joiner-Fox          PHONE NO : 475 3334452  325 Corporate Drive               SE DECISION MADE: 18-AUG-23 Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Pediatric Nailing Platform | Tibia OrthoPediatrics Corp.             510(k) NO: K231266(Traditional) ATTN: Yan  Li                     PHONE NO : 574 2670864  2850 Frontier Drive               SE DECISION MADE: 21-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Natural Cycles Natural Cycles Nordic AB          510(k) NO: K231274(Traditional) ATTN: Raoul  Scherwitzl, PhD      PHONE NO : 46 707 174866____  St Eriksgatan 63b                 SE DECISION MADE: 24-AUG-23 Stockholm  SE 112 34              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SmartCardia 7L Platform SmartCardia SA                    510(k) NO: K231276(Traditional) ATTN: Srinivasan  Murali          PHONE NO : 41 788 750864  EPFL Innovation Park Building C   SE DECISION MADE: 30-AUG-23 Lausanne  CH 1015                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Knotless Suture Anchor Riverpoint Medical, LLC           510(k) NO: K231278(Traditional) ATTN: Bianca Silva de Sousa       PHONE NO : 503 5178001  815 NE 25th Ave                   SE DECISION MADE: 01-AUG-23 Portland OR  97232                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Chemfort® Catheter Adaptor Simplivia Healthcare LTD.         510(k) NO: K231286(Traditional) ATTN: Shay  Shaham                PHONE NO : 97 246 908826  North Industrial Zone             SE DECISION MADE: 02-AUG-23 Kiryat Shmona  IL 1101801         510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: S-Patch Ex Wearable ECG Patch Wellysis Corp.                    510(k) NO: K231289(Traditional) ATTN: DoGyun  Im                  PHONE NO : 82 109 1408475  8F, 425 Teheran-ro, Gangnam-gu    SE DECISION MADE: 30-AUG-23 Seoul  KR 06159                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vscan Air GE Medical Systems Ultrasound and 510(k) NO: K231301(Traditional) ATTN: Bush  Lee                   PHONE NO : 262 3099429  9900 W. Innovation Drive          SE DECISION MADE: 15-AUG-23 Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ancora-SB Aspero Medical, Inc.              510(k) NO: K231323(Traditional) ATTN: Mark  Rentschler            PHONE NO : 303 8347885  320 E. Vine Drive, Suite 101      SE DECISION MADE: 31-AUG-23 Fort Collins CO  80524            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LUX-Dx II (M302); LUX-Dx II+ (M312) Boston Scientific Corp            510(k) NO: K231328(Traditional) ATTN: Melissa  Klamerus           PHONE NO : 651 5826771  4100 Hamline Ave North            SE DECISION MADE: 19-AUG-23 St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: STRETTO™ Cable System Globus Medical Inc.               510(k) NO: K231333(Traditional) ATTN: Jennifer  Antonacci         PHONE NO : 610 9301800  2560 General Armistead Ave.       SE DECISION MADE: 04-AUG-23 Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Organic cotton tampon, Viscose tampon Zhejiang Tianqing Manufacturing Te510(k) NO: K231341(Traditional) ATTN: Roy  Du                     PHONE NO : 86 138 17862379  Lianshi Industrial Park, Nanxun DiSE DECISION MADE: 14-AUG-23 Huzhou  CN 313013                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ActivSight Intraoperative Imaging System Activ Surgical Inc.               510(k) NO: K231344(Traditional) ATTN: Nicholas  Child             PHONE NO : 857 4494840  30 Thomson Place                  SE DECISION MADE: 02-AUG-23 Boston MA  02110                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Dewin Blastocyst Medium (with HSA and without HSA) DonneVie Medical Technology (Shang510(k) NO: K231370(Traditional) ATTN: Hannah Hang Yin             PHONE NO :  Suite 201, Bld 1, 138 Xinjun Ring SE DECISION MADE: 04-AUG-23 Shanghai  CN 201114               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Q-FIX With Needles (Q-FIX With Needles, #0 Suture & Q-FIX With Needles, Minitape) Smith & Nephew Inc.               510(k) NO: K231376(Traditional) ATTN: Pragnya  Bakka              PHONE NO : 512 3913900  150 Minuteman Road                SE DECISION MADE: 09-AUG-23 Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AirLife DuoTherm™ Humidification System Vyaire Medical, Inc.              510(k) NO: K231380(Traditional) ATTN: Megan  Walsh                PHONE NO : 872 2063142  26125 N. Riverwoods Blvd.         SE DECISION MADE: 10-AUG-23 Mettawa IL  60045                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Harvest Dental HD Gum Strip Harvest Dental Products, LLC      510(k) NO: K231389(Traditional) ATTN: Colleen  Boswell            PHONE NO : 714 5853431  905 Columbia Street               SE DECISION MADE: 16-AUG-23 Brea CA  92821                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Intense Pulsed Light System Smedtrum Medical Technology Co., L510(k) NO: K231394(Traditional) ATTN: Crimson  Wu                 PHONE NO : 88 622 2989578 301 1F., No. 8, Ln. 97, Wugong Rd.,   SE DECISION MADE: 09-AUG-23 New Taipei City  TW 248016        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Bladeless Trocar – Artemis Lap Cannula T.A.G. Medical Products Corporatio510(k) NO: K231400(Special) ATTN: Shlomi  Dines               PHONE NO : 972 4 9858400  T.A.G. Medical Products CorporatioSE DECISION MADE: 04-AUG-23 Gaaton  IL 2513000                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: T-Button® A Adjustable Loop UHMWPE Suture PEEK Button, Close Button, T-Button® S Adjustable Loop UHMWPE Suture PEEK Button, Open Button Healthium Medtech Limited         510(k) NO: K231404(Traditional) ATTN: Pankaj  Dawar               PHONE NO : 91 988 6529934  472-D, 13th Cross, 4th Phase, PeenSE DECISION MADE: 04-AUG-23 Bangalore  IN 560058              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: StarFin Premium Medical Technology LLC    510(k) NO: K231407(Traditional) ATTN: Kuowei  Chang               PHONE NO : 781 8914201  1377 Main Street 2nd Floor        SE DECISION MADE: 29-AUG-23 Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Basic Synguard Nitrile Exam Gloves, Powder Free, Blue Colored, Non-Sterile Shandong Intco Medical Products Co510(k) NO: K231408(Traditional) ATTN: Max  Li                     PHONE NO : 86 189 18364816  No. 9888 Qiwang Road, Naoshan InduSE DECISION MADE: 11-AUG-23 Qingzhou  CN 2625000              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Erchonia FX-405 Erchonia Corporation              510(k) NO: K231409(Traditional) ATTN: Travis  Sammons             PHONE NO : 888 2420571  650 Atlantis Road                 SE DECISION MADE: 11-AUG-23 Melbourne FL  32904               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EnSite™ X EP System Abbott Medical                    510(k) NO: K231415(Traditional) ATTN: Alyssa  Timmers             PHONE NO : 651 7563706  One St. Jude Medical Drive        SE DECISION MADE: 10-AUG-23 St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ENDOGATOR™ Hybrid Irrigation Tubing Medivators                        510(k) NO: K231418(Traditional) ATTN: Disha  Kabrawala            PHONE NO : 732 3197766  14605 28th Avenue North           SE DECISION MADE: 14-AUG-23 Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aura 10 PET/CT XEOS Medical                      510(k) NO: K231420(Traditional) ATTN: Bjorn  Delbeecke            PHONE NO : 0032 09 2777794  Ottergemsesteenweg-Zuid 808 Bus 35SE DECISION MADE: 10-AUG-23 Gent  BE 9000                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Precision GI Limaca Medical Ltd                510(k) NO: K231422(Traditional) ATTN: Assaf  Klein                PHONE NO : 972 54 2299572  3 Ha'Rimon street Mevo-Carmel ScieSE DECISION MADE: 28-AUG-23 En Ha'Emeq  IL 1925000            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: The Sensititre YeastOne Susceptibility System with Rezafungin in the dilution range of 0.008-8ug/mL Thermo Fisher Scientific          510(k) NO: K231433(Traditional) ATTN: Cynthia  Knapp              PHONE NO : 800 87189093 224117 1 Thermo Fisher Way               SE DECISION MADE: 31-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: DESS Dental Smart Solutions Terrats Medical SL                510(k) NO: K231434(Traditional) ATTN: Roger  Terrats              PHONE NO : 34 935 646006  Carrer Mogoda 75-99               SE DECISION MADE: 14-AUG-23 Barbera del Valles  ES 08210      510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: KIMTECH™ Polaris™ Xtra Nitrile Powder-Free Exam Gloves Tested for Use with Chemotherapy Drugs, Opioid Fentanyl Citrate, Simulated Gastric Acid and Fentanyl in Simulated Gastric Acid Kimberly-Clark Corporation        510(k) NO: K231435(Traditional) ATTN: Kimberly  Tempas            PHONE NO : 920 7214084  1400 Holcomb Bridge Road          SE DECISION MADE: 28-AUG-23 Roswell GA  30076                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free White, Black, and Purple Nitrile Examination Glove S&S Glove Corporation             510(k) NO: K231439(Traditional) ATTN: Poppy Farrah Rossa          PHONE NO : 84 283 8725999  Lot 4, D6 Road, Dat Do I IndustriaSE DECISION MADE: 11-AUG-23 Ba Ria-Vung Tau  VN VN790000      510(k) STATEMENT                                                       DEVICE: Implant-One System Implant Logistics, Inc.           510(k) NO: K231455(Traditional) ATTN: Thomas  Arendt              PHONE NO : 1 608 4984855  711 Spartan Drive                 SE DECISION MADE: 15-AUG-23 Sparta WI  54656                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SPARK Scan SPARK Neuro Inc.                  510(k) NO: K231457(Traditional) ATTN: Marinela  Gombosev          PHONE NO : 949 5847331  212 West 18th Street, Unit 17A    SE DECISION MADE: 18-AUG-23 New York NY  10011                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Extremity Staple restor3d                          510(k) NO: K231458(Traditional) ATTN: Anika  Moorjani             PHONE NO : 501 2403476  311 West Corporation Street       SE DECISION MADE: 03-AUG-23 Durham NC  27701                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Xpert Xpress CoV-2/Flu/RSV plus Cepheid®                          510(k) NO: K231481(Traditional) ATTN: Suzette  Chance             PHONE NO : 262 6231775  904 Caribbean Drive               SE DECISION MADE: 17-AUG-23 Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celerity™ HP Chemical Indicator;  Celerity™ HP Multivariable Chemical Indicator; VERIFY HPU Chemical Indicator; VERIFY VH2O2 Indicator Tape STERIS                            510(k) NO: K231488(Traditional) ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Celerity 20 HP Biological Indicator; VERIFY V24 Self-Contained Biological Indicator STERIS Corporation                510(k) NO: K231490(Traditional) ATTN: Gregory  Land               PHONE NO : 440 3927424  5960 Heisley Rd                   SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TA™ Stapler and Loading Unit with DST Series™ Technology Covidien                          510(k) NO: K231491(Traditional) ATTN: Emily  Jacobs               PHONE NO : 860 9336557  60 Middletown Ave.                SE DECISION MADE: 16-AUG-23 North Haven CT  06473             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NITINEX Memory Compression Staple Vilex, LLC                        510(k) NO: K231493(Traditional) ATTN: Brock  Johnson              PHONE NO : 801 9164157  111 Moffitt Street                SE DECISION MADE: 11-AUG-23 McMinnville TN  37110             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TITAN 3-D Wedge System Paragon 28 Inc                    510(k) NO: K231496(Traditional) ATTN: Haylie  Hertz               PHONE NO : 303 7200017  14445 Grasslands Drive            SE DECISION MADE: 22-AUG-23 Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Vis-U-All Low Temperature Sterilization Pouches Steris Corporation                510(k) NO: K231500(Traditional) ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458  5960 Heisley Road                 SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: PRO-LITE Sterilization Tray STERIS Corporation                510(k) NO: K231501(Traditional) ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458  5960 Heisley Road                 SE DECISION MADE: 07-AUG-23 Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CUPTIMIZE™ Advanced DePuy Orthopaedics, Inc           510(k) NO: K231503(Traditional) ATTN: Sierra  Robinson            PHONE NO : 850 2519921  700 Orthopaedic Dr                SE DECISION MADE: 22-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Current Health System Current Health Ltd                510(k) NO: K231506(Special) ATTN: Giovanni  Maggi             PHONE NO : 44 131 2858101  The Stamp Office, Level 3, 10 WateSE DECISION MADE: 24-AUG-23 Edinburgh  GB EH1 3EG             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) Xiantao Zhibo Non-Woven Products C510(k) NO: K231510(Traditional) ATTN: Fen  Peng                   PHONE NO : 86 188 72609993  No. 8 Hefeng Industrial Park, PengSE DECISION MADE: 22-AUG-23 Xiantao  CN                       510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VITROS Immunodiagnostic Products CEA Reagent Pack Ortho Clinical Diagnostics        510(k) NO: K231517(Traditional) ATTN: Rebecca  Lewis              PHONE NO : 440 7917 427649  Felindre Meadows Pencoed          SE DECISION MADE: 23-AUG-23 Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: VITROS Immunodiagnostic Products CA 19-9TM Reagent Pack Ortho Clinical Diagnostics        510(k) NO: K231525(Traditional) ATTN: Declan  Hynes               PHONE NO : 44 0750 5370257  Felindre Meadows Pencoed          SE DECISION MADE: 09-AUG-23 Bridgend  GB CF35 5PZ             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SofWave System Sofwave Medical Ltd.              510(k) NO: K231537(Traditional) ATTN: Ruthie  Amir, MD            PHONE NO : 97 254 3003164  1 Ha-Otsma St.                    SE DECISION MADE: 28-AUG-23 Yokneam Ilit  IL 2069200          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Meical Diode Laser, Model S1Pro Wuhan Pioon Technology Co., Ltd.  510(k) NO: K231548(Traditional) ATTN: Feng  Zhang                 PHONE NO : 86 180 62448535  7th Floor, A21 of Sino Pharm BuildSE DECISION MADE: 03-AUG-23 Wuhan  CN 430075                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZENEX FreeMilling & CCM Cast Abutment Izenimplant Co., Ltd.             510(k) NO: K231557(Traditional) ATTN: Ji-Hwan  Jeong              PHONE NO : 82 31 6620657  1, 2Dong, 26-32, Suworam 4-Gil, SeSE DECISION MADE: 24-AUG-23 Pyeongtaek-Si  KR 17703           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Medtronic Xomed, Inc.             510(k) NO: K231580(Traditional) ATTN: Alexandra  Oliver           PHONE NO : 904 3328936  6743 Southpoint Drive North       SE DECISION MADE: 30-AUG-23 Jacksonville FL  32216            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Route 92 Medical Full Length 054 Access System Route 92 Medical, Inc.            510(k) NO: K231583(Special) ATTN: Kirsten  Valley             PHONE NO : 650 2798427  155 Bovet Road, Suite 100         SE DECISION MADE: 15-AUG-23 San Mateo CA  94402               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sapphire X3 Anterior Cervical Plate System Spinal Elements, Inc              510(k) NO: K231593(Traditional) ATTN: Julie  Lamothe              PHONE NO : 760 6071816  3115 Melrose Dr., Suite 200       SE DECISION MADE: 02-AUG-23 Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stryker MP, Mandible, HMMF and MMF AXS Screws Stryker Leibinger GmbH & Co. KG   510(k) NO: K231599(Traditional) ATTN: Amelia  Kesti               PHONE NO : 269 3305919  Boetzinger Strasse 41             SE DECISION MADE: 24-AUG-23 Freiburg  DE D-79111              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing GA Health Company Limited         510(k) NO: K231602(Traditional) ATTN: Cindy  Ye                   PHONE NO : 852 28339010  Unit 18, 21/F, Metropole Square, 2SE DECISION MADE: 01-AUG-23 Hong Kong  HK                     510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Instrument Case Cochlear Americas                 510(k) NO: K231604(Special) ATTN: Whitney  Alexander          PHONE NO : 719 3378620  10350 Park Meadows Drive          SE DECISION MADE: 24-AUG-23 Lone Tree CO  80124               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: HOLO Portal™ Surgical Guidance System Surgalign Spine Technologies      510(k) NO: K231611(Traditional) ATTN: Jeremy  Markovich           PHONE NO : 760 5224378  520 Lake Cook Road Suite 315      SE DECISION MADE: 31-AUG-23 Deerfield IL  60015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZEUS IFA(TM) nDNA Test System, ZEUS dIFine ZEUS Scientific                   510(k) NO: K231616(Traditional) ATTN: Mark  Kopnitsky             PHONE NO : 908 5263744  200 Evans Way                     SE DECISION MADE: 31-AUG-23 Branchburg NJ  08876              510(k) STATEMENT                                                       DEVICE: Nuubo Smart Smart Solutions Technologies SL   510(k) NO: K231620(Traditional) ATTN: Borja Gonzal Vez            PHONE NO :  Paseo de la Castellena 200        SE DECISION MADE: 01-AUG-23 Madrid  ES 28046                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Distal Elbow Plating System Skeletal Dynamics Inc             510(k) NO: K231623(Traditional) ATTN: Alexandra  Rodriguez Rojas  PHONE NO : 305 5967585  7300 North Kendall Drive          SE DECISION MADE: 28-AUG-23 Miami FL  33156                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: OSPREY Closed IV Catheter System (OspreyV2) SkyDance Vascular, Inc.           510(k) NO: K231626(Traditional) ATTN: Scott  Pease                PHONE NO : 678 6898010  3058 Millcreek Road               SE DECISION MADE: 31-AUG-23 Pleasant Grove UT  84062          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NorthStar OCT System SeaSpine Inc.                     510(k) NO: K231654(Traditional) ATTN: Jesse  Albright             PHONE NO : 815 3422428  5770 Armada Dr.                   SE DECISION MADE: 03-AUG-23 Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Brainomix 360 e-MRI Brainomix Limited                 510(k) NO: K231656(Traditional) ATTN: Zsolt  Szrnka               PHONE NO : 0044 79 49013914  First Floor Seacourt Tower West WaSE DECISION MADE: 30-AUG-23 Oxford  GB OX2 0JJ                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: P200TE (A10700) Optos Plc                         510(k) NO: K231673(Traditional) ATTN: Rachel  Reay                PHONE NO : 00 441 383843300  Queensferry House, Carnegie CampusSE DECISION MADE: 18-AUG-23 Dunfermline  GB KY11 8GR          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CALLISTO eye Carl Zeiss Meditec AG             510(k) NO: K231676(Traditional) ATTN: Hans-Joachim  Miesner       PHONE NO : 49 3641 220362  Goeschwitzer Strasse 51-52        SE DECISION MADE: 28-AUG-23 Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AccelFix Lumbar Expandable Cage System L&K BioMed Co., Ltd.              510(k) NO: K231680(Special) ATTN: Katherine  Kim              PHONE NO : 82 10 54770325  #101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 24-AUG-23 Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal Prevest Denpro Limited            510(k) NO: K231696(Traditional) ATTN: Atul  Modi                  PHONE NO : 941___ 9194280  Unit II, Export Promotion IndustriSE DECISION MADE: 11-AUG-23 Bari Brahmana  IN 181133          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Holmium Medical Laser Allengers Global Healthcare Privat510(k) NO: K231718(Traditional) ATTN: Harpreet  Singh             PHONE NO : 91 1762 272600  Room No.5, Khasra no. 79, BhankarpSE DECISION MADE: 18-AUG-23 Derabassi, District- Mohali  IN 14510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4 McGovern Medical School           510(k) NO: K231731(Traditional) ATTN: K. Lance  Gould             PHONE NO : 713 5006611  6431 Fannin Street, MSB 4.256     SE DECISION MADE: 21-AUG-23 Houston TX  77030                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: MA012 Aluminum wheelchair, MS019 steel wheelchair Sichuan AST Medical Equipment Co.,510(k) NO: K231750(Traditional) ATTN: Mae  Tse                    PHONE NO : 86 830 8130333  No.58 JinPeng Road, Area C, West ISE DECISION MADE: 15-AUG-23 Luzhou City  CN 646100            510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Stable-C Interbody System Nexus Spine, LLC                  510(k) NO: K231763(Traditional) ATTN: Jared  Crocker              PHONE NO : 801 7028592  2825 East Cottonwood Parkway SuiteSE DECISION MADE: 21-AUG-23 Salt Lake City UT  84121          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electrosurgical Generator ESG-410 and Accessories (WA91327U, WA91327W), Accessories: Foot switches (WA91311W, WA91321W) Olympus Winter & Ibe GmbH         510(k) NO: K231777(Traditional) ATTN: Ian  Pericevic              PHONE NO : 49 40 669660  Kuehnstrasse 61                   SE DECISION MADE: 18-AUG-23 Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: primaLOK™ SP Interspinous Fusion System Wenzel Spine, Inc.                510(k) NO: K231807(Traditional) ATTN: William  Wilson             PHONE NO : 512 4690600  1130 Rutherford Lane, Suite 200   SE DECISION MADE: 15-AUG-23 Austin TX  78753                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zavation Connector System Zavation Medical Products, LLC    510(k) NO: K231811(Traditional) ATTN: Noah  Slack                 PHONE NO : 601 9191119  3670 Flowood Dr.                  SE DECISION MADE: 22-AUG-23 Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NOxBOXi Nitric Oxide Delivery System Linde Gas & Equipment Inc.        510(k) NO: K231823(Special) ATTN: Dave  Loflin                PHONE NO : 412 8743315  208 W Main St.                    SE DECISION MADE: 11-AUG-23 Livingston TN  38570              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Xenix Medical Sacroiliac Fixation System HT Medical d.b.a. Xenix Medical   510(k) NO: K231829(Traditional) ATTN: Teresa  Cherry              PHONE NO : 888 5948633  111 W Jefferson St., Suite 100    SE DECISION MADE: 15-AUG-23 Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: TiLink-L Joint Fusion System SurGenTec                         510(k) NO: K231831(Special) ATTN: Andrew  Shoup               PHONE NO : 561 9907882  911 Clint Moore Rd                SE DECISION MADE: 03-AUG-23 Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: RxSight® Insertion Device (63002) RxSight, Inc.                     510(k) NO: K231838(Traditional) ATTN: Maureen  OConnell           PHONE NO : 978 2071245___  100 Columbia                      SE DECISION MADE: 15-AUG-23 Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Arthrex TightRope II Arthrex Inc.                      510(k) NO: K231857(Traditional) ATTN: Kristi  Frisch              PHONE NO : 1 239 5984302 73849 1370 Creekside Boulevard          SE DECISION MADE: 08-AUG-23 Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Grappler Suture Anchor System Paragon 28, Inc.                  510(k) NO: K231867(Traditional) ATTN: Edward  Wells-Spicer        PHONE NO : 585 4552810  14445 Grasslands Dr               SE DECISION MADE: 21-AUG-23 Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Polaris Bipolar Electrosurgical Generator (29-1000); Polaris Irrigation Module (29-1600); Polaris Light Source Module (29-1900); Dual Footswitch (29-1020) Kirwan Surgical Products LLC      510(k) NO: K231872(Traditional) ATTN: Matthew  Prario             PHONE NO : 781 8349500  180 Enterprise Drive              SE DECISION MADE: 25-AUG-23 Marshfield MA  02050              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Medline UNITE® REFLEX® Nitinol Staple System Medline Industries, LP            510(k) NO: K231885(Traditional) ATTN: Jennifer  Mason             PHONE NO : 847 6433652  Three Lakes Drive                 SE DECISION MADE: 09-AUG-23 Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Montage-QS Settable, Resorbable Bone Putty Orthocon, Inc.                    510(k) NO: K231903(Traditional) ATTN: Aniq  Darr                  PHONE NO : 855 4759175  700 Fairfield Avenue- Suite 1     SE DECISION MADE: 25-AUG-23 Stamford CT  06902                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Electro-Spec Steri-Caps Electro-Spec, Inc                 510(k) NO: K231905(Traditional) ATTN: Jeff  Smith                 PHONE NO : 1 317 7390924  1800 Commerce Parkway             SE DECISION MADE: 14-AUG-23 Franklin IN  46131                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Mineral Collagen Composite Bioactive Extra Moldable Collagen Matrix, Inc.             510(k) NO: K231942(Special) ATTN: Victoria  Augustine         PHONE NO : 646 2229564  15 Thornton Rd.                   SE DECISION MADE: 02-AUG-23 Oakland NJ  07436                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CATAMARAN SI Joint Fusion System Tenon Medical, Inc.               510(k) NO: K231944(Traditional) ATTN: Susan  Noreiga              PHONE NO : 650 7931966  104 Cooper Court                  SE DECISION MADE: 24-AUG-23 Los Gatos CA  95032               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Aristotle 18 Guidewire; Aristotle 24 Guidewire Scientia Vascular, Inc.           510(k) NO: K231954(Special) ATTN: Bailey  Johannsen           PHONE NO : 888 3859016  2460 S 3270 W                     SE DECISION MADE: 01-AUG-23 West Valley City UT  84119        510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EXPD 4357; EXPD 4357P DRTECH Corporation                510(k) NO: K231959(Special) ATTN: Lee  Youna                  PHONE NO : 82 31 7797710  Suite No.1, 2 Floor/Suite No. 2, 3SE DECISION MADE: 01-AUG-23 Seongnam-si  KR 13216             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: NIBPCuff Shenzhen SINO-K Medical Technology510(k) NO: K231961(Traditional) ATTN: Lao  Chengxin               PHONE NO : 86 137 15333326  Room401,Bldg2,Veteran Ind.city,GonSE DECISION MADE: 30-AUG-23 Shenzhen  CN 518115               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: REAL INTELLIGENCE™ CORI™ Blue Belt Technologies, Inc.      510(k) NO: K231963(Special) ATTN: Corrine  Herlinger          PHONE NO : 412 5526428  2875 Railroad Street              SE DECISION MADE: 01-AUG-23 Pittsburgh PA  15222              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: BioSieve™ Marijuana Test Panel 50; BioSieve™ Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Strip 20; BioSieve™ Dx Marijuana Test Strip 50; BioSieve™ Dx Marijuana Test Panel 20; BioSieve™ Dx Marijuana Test Panel 50 VivaChek Biotech (Hangzhou) Co., L510(k) NO: K231978(Traditional) ATTN: Jessica  Chen               PHONE NO : 86 182 57349413  Floor 2, Block 2, 146 East ChaofenSE DECISION MADE: 31-AUG-23 Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sensititre 20-24-hour Haemophilus influenzae/Streptococcus pneumoniae MIC or Breakpoint Susceptibility System with Dalbavancin in the dilution range of 0.0005-2µg/ml Thermo Fisher Scientific          510(k) NO: K231988(Traditional) ATTN: Joel  Mathew                PHONE NO : 978 9074417  One Thermo Fisher Way             SE DECISION MADE: 30-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Sulbactam-durlobactam in the dilution range of 0.015/4-32/4 ug/mL Thermo Fisher Scientific          510(k) NO: K231994(Traditional) ATTN: Cynthia  Knapp              PHONE NO : 1 216 2122844  One Thermo Fisher Way             SE DECISION MADE: 25-AUG-23 Oakwood Village OH  44146         510(k) STATEMENT                                                       DEVICE: HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue); HEALICOIL PK Suture Anchor with Needles, ULTRATAPE (Blue Cobraid) Smith & Nephew, Inc.              510(k) NO: K232005(Special) ATTN: Camille  Fleischer          PHONE NO : 978 7491057  150 Minuteman Road                SE DECISION MADE: 04-AUG-23 Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LEGACY®  IPC IG Technology Ltd                 510(k) NO: K232006(Third Party - Traditional) ATTN: Ivan  Green                 PHONE NO : 440 7770 386797  Wylcut House, 316 Petre St        SE DECISION MADE: 04-AUG-23 Sheffield  GB S33 0AW             510(k) STATEMENT                                   THIRD PARTY REVIEW  DEVICE: Disposable Medical Examination Nitrile Gloves Raxwell Industrial LLC            510(k) NO: K232008(Third Party - Traditional) ATTN: Xianda  Yao                 PHONE NO : 1 765 4300178___  20323 Bristol Bluff Ln            SE DECISION MADE: 08-AUG-23 Richmond TX  77407                510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: iTEMPSHIELD AION Biosystems Inc.              510(k) NO: K232010(Third Party - Traditional) ATTN: Joseph  Azary               PHONE NO : 203 2426670  12 Plymouth Road                  SE DECISION MADE: 04-AUG-23 Darien CT  06820                  510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW  DEVICE: ATMOS Scope (507.7000.0); ATMOS Scope Pro (507.7050.0); ATMOS Scope iPrime (507.7060.0) ATMOS MedizinTechnik GmbH & Co. KG510(k) NO: K232015(Traditional) ATTN: Reinhold  Storch            PHONE NO : 49 7653 689647  Ludwig-Kegel-Str. 16              SE DECISION MADE: 03-AUG-23 Lenzkirch  DE 79853               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ingenia Elition R5.7.1 SP4 MR Systems Philips Medical Systems Nederland 510(k) NO: K232030(Special) ATTN: Ioana  Ulea                 PHONE NO : 31 618 345875  Veenpluis 6                       SE DECISION MADE: 02-AUG-23 Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate Grand Work Plastic Products Co., L510(k) NO: K232039(Special) ATTN: Wu  Yuli                    PHONE NO : 86 311 66179668  Donggao Industrial Zone           SE DECISION MADE: 09-AUG-23 Zanhuang  CN 050000               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Ceribell Instant EEG Headband Ceribell, Inc.                    510(k) NO: K232052(Special) ATTN: Raymond  Woo                PHONE NO : 650 5564349  360 North Pastoria Avenue         SE DECISION MADE: 08-AUG-23 Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: YosemiteView 4343W/YosemiteView 3643W CareRay Digital Medical Technology510(k) NO: K232058(Special) ATTN: Xu  Wei                     PHONE NO : 86 512 86860288  A2-201/B3-501, Biobay,218 Xinghu SSE DECISION MADE: 03-AUG-23 Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Efai Pacs Picture Archiving and Communication System Pro Ever Fortune.AI Co., Ltd.         510(k) NO: K232100(Special) ATTN: Joseph  Chang               PHONE NO : 866 4 23226363  8 F., No. 573, Sec. 2, Taiwan BlvdSE DECISION MADE: 08-AUG-23 Taichung City  TW 403020          510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CoreLink Navigation Instruments CoreLink, LLC                     510(k) NO: K232116(Special) ATTN: Steven  Mounts              PHONE NO : 888 3497808___  2072 Fenton Logistics Park        SE DECISION MADE: 16-AUG-23 St. Louis MO  63026               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EEA™Circular Stapler with Tri-Staple™ Technology and OrVil™ Transoral Circular Stapler Anvil Covidien                          510(k) NO: K232126(Special) ATTN: Helen  Chen                 PHONE NO : 86 21 33230135  Room 501, 502, 601, 602, No. 3 BuiSE DECISION MADE: 16-AUG-23 Min Hang District, Shanghai  CN 20510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 21HQ513D, 32HL512D, 31HN713D, 32HQ713D LG Electronics Inc.               510(k) NO: K232127(Special) ATTN: Daseul  An                  PHONE NO : 82 31 80665641  168, Suchul-daero                 SE DECISION MADE: 15-AUG-23 Gumi-si  KR 39368                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LifeSPARC System CardiacAssist, Inc.               510(k) NO: K232132(Special) ATTN: Arielle  Drummond           PHONE NO : 412 8899021  620 Alpha Drive                   SE DECISION MADE: 03-AUG-23 Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: CD Horizon ModuLeX FNS Screw Set (Fenestrated Screw); CD Horizon ModuLeX Spinal System (Modular Extended Tab Head) Medtronic Sofamor Danek USA, Inc. 510(k) NO: K232141(Special) ATTN: Kelly  McDonnell            PHONE NO : 1 651 2699806  1800 Pyramid Place                SE DECISION MADE: 16-AUG-23 Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Sterile Products of the APTUS System Medartis AG                       510(k) NO: K232144(Special) ATTN: Claudia  De Santis          PHONE NO : 41 61 6333434  Hochbergerstrasse 60E             SE DECISION MADE: 18-AUG-23 Basel  CH 4057                    510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ZSFab Cervical Interbody System ZSFab Inc.                        510(k) NO: K232150(Special) ATTN: Xuewei  Ma                  PHONE NO : 617 4688665  96 Clematis Ave, Suite 2F         SE DECISION MADE: 18-AUG-23 Walthan MA  02453                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Avéli Revelle Aesthetics, Inc.          510(k) NO: K232153(Special) ATTN: Melissa  Viotti             PHONE NO : 650 3365985  2570 W El Camino Real, Suite 310  SE DECISION MADE: 18-AUG-23 Mountain View CA  94040           510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control Stryker Corporation               510(k) NO: K232157(Special) ATTN: Janki  Bhatt                PHONE NO : 669 2153045  5900 Optical Ct                   SE DECISION MADE: 18-AUG-23 San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome Boston Scientific Corporation     510(k) NO: K232162(Special) ATTN: Stephanie  Gorman           PHONE NO : 508 3820441  100 Boston Scientific Way         SE DECISION MADE: 14-AUG-23 Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: SM-IV Sedecal SA                        510(k) NO: K232185(Special) ATTN: Mª Luisa Gómez  de Agüero   PHONE NO : 34 91 6280544  C/ Pelaya, 9 - 13 Pol. Ind. Río DeSE DECISION MADE: 21-AUG-23 Algete  ES 28110                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter Medtronic Vascular                510(k) NO: K232190(Special) ATTN: Colleen  Gentile            PHONE NO : 1 508 8436178  37A Cherry Hill Drive             SE DECISION MADE: 22-AUG-23 Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: OMNI Surgical System Sight Sciences Inc.,              510(k) NO: K232214(Special) ATTN: Ranjani  Madhavan           PHONE NO : 737 2470998  4040 Campbell Ave, Suite 100      SE DECISION MADE: 25-AUG-23 Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Quantra Hemostasis Analyzer HemoSonics, LLC                   510(k) NO: K232215(Special) ATTN: Debbie  Winegar             PHONE NO : 919 2446990  4020 Stirrup Creek Drive, Suite 10SE DECISION MADE: 24-AUG-23 Durham NC  27703                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Zenius™ Spinal System Medyssey USA, Inc.                510(k) NO: K232218(Special) ATTN: Youngsu  Jang               PHONE NO : 847 4270200  43176 Business Park Dr Ste 107    SE DECISION MADE: 24-AUG-23 Temecula CA  92590                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: ARROW Off-Centred Humeral Insert FH Industrie                      510(k) NO: K232226(Special) ATTN: Naoual  Rahimi              PHONE NO : 33 02 56102046  6 rue Nobel, Zi De Kernevez       SE DECISION MADE: 29-AUG-23 Quimper  FR 29000                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: EVO 700 series high speed handpiece Ttbio Corp.                       510(k) NO: K232243(Special) ATTN: Sheng-Chieh  Su             PHONE NO : 886 4 23595958  2F., No.7, 6th Road Industry Park SE DECISION MADE: 23-AUG-23 Taichung  CN 40755                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: RAYSCAN a-Expert3D Ray Co., Ltd.                     510(k) NO: K232287(Special) ATTN: Sooji  Huh                  PHONE NO : 82 605 1000  1F~3F, 4F(Part), 5F, 265, Daeji-RoSE DECISION MADE: 31-AUG-23 Yongin-si  KR 16882               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Essenz HLM, Essenz ILBM LivaNova Deutschland GmbH         510(k) NO: K232291(Special) ATTN: Florian  Goetz              PHONE NO : 49 89 32301236  Lindberghstr. 25                  SE DECISION MADE: 24-AUG-23 Munich  DE 80939                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LAA Exclusion System Syntheon, LLC                     510(k) NO: K232295(Special) ATTN: Toygar  Unal                PHONE NO : 973 9978532  13755 SW 119 Avenue               SE DECISION MADE: 30-AUG-23 Miami FL  33186                   510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LnK Spinal Fixation System /OpenLoc-L Spinal Fixation System, AccelFix Spinal Fixation System L&K Biomed Co., Ltd.              510(k) NO: K232311(Special) ATTN: Katherine  Kim              PHONE NO : 82 10 54770325  #101, 201, 202 16-25, DongbaekjungSE DECISION MADE: 14-AUG-23 Yongin-si  KR 17015               510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: LIGACLIP Endoscopic Rotating Multiple Clip Applier 12mm L (ER420); LIGACLIP Endoscopic Rotating Multiple Clip Applier 10mm M/L (ER320) Ethicon Endo Surgery, LLC.        510(k) NO: K232313(Special) ATTN: Lakrisha  Tinner            PHONE NO : 517 3377475  475 Calle C                       SE DECISION MADE: 29-AUG-23 Guaynabo  PR 00969                510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: StealthFix Intraosseous Fixation System Medartis Inc.                     510(k) NO: K232324(Special) ATTN: Chelsea  Kozior             PHONE NO : 610 7318650  1195 Polk Drive                   SE DECISION MADE: 30-AUG-23 Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: AC3™ Series IABP Arrow International, LLC          510(k) NO: K232343(Special) ATTN: Sheila  Payzant             PHONE NO : 763 6564290  3015 Carrington Mill Blvd         SE DECISION MADE: 30-AUG-23 Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Powder Free Nitrile Examination Gloves (Black) Shanxi Hongjin Plastic Technology 510(k) NO: K232353(Special) ATTN: Wu  Zhigang                 PHONE NO : 86 311 66179668  Coal Bed Gas Industrial Zone, Qu'eSE DECISION MADE: 31-AUG-23 Linfen  CN 042300                 510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: Treace Medical Concepts (TMC) Compression Implant System Treace Medical Concepts           510(k) NO: K232387(Special) ATTN: Brittany  Grochala          PHONE NO : 515 8650494  100 Palmetto Park Place           SE DECISION MADE: 28-AUG-23 Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA                                                       DEVICE: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio Ultradent Product, Inc.           510(k) NO: K232498(Third Party - Traditional) ATTN: Ruth  Gardner               PHONE NO : 801 5534431  505 West Ultradent Drive (10200 SoSE DECISION MADE: 18-AUG-23 South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA                                   THIRD PARTY REVIEW                 TOTAL 510(k)s THIS PERIOD   310                                                     TOTAL WITH SUMMARIES        289                                                     TOTAL WITH STATEMENTS        21                                        

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#CBD #Hemp http://www.fda.gov/medical-devices/510k-clearances/august-2023-510k-clearances September 6, 2023 2:00 pm

PubMed: Individually tailored dosage regimen of full-spectrum Cannabis extracts for autistic core and comorbid symptoms: a real-life report of multi-symptomatic benefits

PubMed: Individually tailored dosage regimen of full-spectrum Cannabis extracts for autistic core and comorbid symptoms: a real-life report of multi-symptomatic benefits

Front Psychiatry. 2023 Aug 21;14:1210155. doi: 10.3389/fpsyt.2023.1210155. eCollection 2023.

ABSTRACT

Autism Spectrum Disorders (ASD) may significantly impact the well-being of patients and their families. The therapeutic use of cannabis for ASD has gained interest due to its promising results and low side effects, but a consensus on treatment guidelines is lacking. In this study, we conducted a retrospective analysis of 20 patients with autistic symptoms who were treated with full-spectrum cannabis extracts (FCEs) in a response-based, individually-tailored dosage regimen. The daily dosage and relative proportions of cannabidiol (CBD) and tetrahydrocannabinol (THC) were adjusted based on treatment results following periodic clinical evaluation. Most patients (80%) were treated for a minimum of 6 months. We have used a novel, detailed online patient- or caregiver-reported outcome survey that inquired about core and comorbid symptoms, and quality of life. We also reviewed patients’ clinical files, and no individual condition within the autistic spectrum was excluded. This real-life approach enabled us to gain a clearer appraisal of the ample scope of benefits that FCEs can provide for ASD patients and their families. Eighteen patients started with a CBD-rich FCE titrating protocol, and in three of them, the CBD-rich (CBD-dominant) FCE was gradually complemented with low doses of a THC-rich (THC-dominant) FCE based on observed effects. Two other patients have used throughout treatment a blend of two FCEs, one CBD-rich and the other THC-rich. The outcomes were mainly positive for most symptoms, and only one patient from each of the two above-mentioned situations displayed important side effects one who has used only CBD-rich FCE throughout the treatment, and another who has used a blend of CBD-Rich and THC-rich FCEs. Therefore, after FCE treatment, 18 out of 20 patients showed improvement in most core and comorbid symptoms of autism, and in quality of life for patients and their families. For them, side effects were mild and infrequent. Additionally, we show, for the first time, that allotriophagy (Pica) can be treated by FCEs. Other medications were reduced or completely discontinued in most cases. Based on our findings, we propose guidelines for individually tailored dosage regimens that may be adapted to locally available qualified FCEs and guide further clinical trials.

PMID:37671290 | PMC:PMC10475955 | DOI:10.3389/fpsyt.2023.1210155

https://pubmed.ncbi.nlm.nih.gov/37671290/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230906190655&v=2.17.9.post6+86293ac September 6, 2023 10:00 am

PubMed: Analgesic and Anti-Inflammatory Effects of 1% Tropical Cannabidiol Gel in Animal Models

PubMed: Analgesic and Anti-Inflammatory Effects of 1% Tropical Cannabidiol Gel in Animal Models

Cannabis Cannabinoid Res. 2023 Sep 5. doi: 10.1089/can.2023.0070. Online ahead of print.

ABSTRACT

Introduction: Cannabidiol (CBD), a phytocannabinoid isolated from cannabis plants, is an interesting candidate for studying its anti-inflammatory effects, especially in the pre-clinical and animal models. Its anti-inflammatory effects, such as reduction of edema and arthritis, have been demonstrated in animal models. However, topical CBD administration requires further evaluation of CBD dosage and efficacy in animal models and clinical settings. Methods: This in vivo study investigated the anti-inflammatory effects of topical CBD administration in an animal model. Scientific experiments, including the formalin test, writhing test, carrageenan-induced edema, histopathological examination, and detection of various proinflammatory mediators, were performed. Results: The anti-inflammatory effects in vivo after inflammation induction, represented by decreased times of paw licking, degree of paw edema, and decreased writhing response, showed that 1% of tropical CBD use had significantly comparable or better anti-inflammatory effects when compared with tropical diclofenac, an anti-inflammatory agent. Moreover, the anti-inflammatory effects were significant compared with the placebo. In addition, the histopathological examination showed that topical CBD drastically reduced leukocyte infiltration and the degree of inflammation. This study also showed that the levels of various proinflammatory mediators in the plasma of mice treated with topical CBD did not differ from those treated with diclofenac. Conclusions: The topical administration of 1% CBD gel is a potentially effective candidate for an anti-inflammatory agent. Candidate for an anti-inflammatory agent.

PMID:37669453 | DOI:10.1089/can.2023.0070

https://pubmed.ncbi.nlm.nih.gov/37669453/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230905190552&v=2.17.9.post6+86293ac September 5, 2023 10:00 am

Government talks indicate hemp advancing in Indian state of Himachal Pradesh

Government talks indicate hemp advancing in Indian state of Himachal Pradesh
The Indian state of Himachal Pradesh could soon see hemp legalized, according to signals from recent government deliberations. A committee headed by state Revenue Minister Jagat Singh Negi has recommended …

Government talks indicate hemp advancing in Indian state of Himachal Pradesh Read More »


#CBD #Hemp
https://hemptoday.net/government-talks-indicate-hemp-advancing-in-indian-state-of-himachal-pradesh/
September 5, 2023 5:34 am

PubMed: Different nanocellulose morphologies (cellulose nanofibers, nanocrystals and nanospheres) extracted from Sunn hemp (Crotalaria Juncea)

PubMed: Different nanocellulose morphologies (cellulose nanofibers, nanocrystals and nanospheres) extracted from Sunn hemp (Crotalaria Juncea)

Int J Biol Macromol. 2023 Sep 1:126657. doi: 10.1016/j.ijbiomac.2023.126657. Online ahead of print.

ABSTRACT

Nanocellulose of different morphologies was extracted from Sunn Hemp (Crotalaria Juncea) using acid hydrolysis. The work focused on two objectives: first, to valorize the Sunn Hemp fibers for nanocellulose (NC) production, and second, to study the effects of acid concentration on different morphologies of NC and their properties. The study extracted nanocellulose at five different concentrations of H2SO4: 16 %, 32 %, 48 %, 64 %, and 72 %. Obtained nanocellulose was characterized by Scanning Electron Microscopy (FE-SEM), Atomic Force Microscopy (AFM), Fourier Transform Infrared Spectroscopy (FTIR), X-ray Diffraction (XRD) and Thermogravimetric Analysis (TGA). AFM and FE-SEM confirmed the production of three different morphologies of nanocellulose. The NC-32 had a web-like structure typically observed for cellulose nanofibrils (CNF), whereas NC-48 and NC-64 were observed as cellulose nanocrystals (CNC) with rod-like and needle-like shapes, respectively, and NC-72 displayed spherical particles termed cellulose nanospheres (CNS). The total crystallinity index of NC was calculated using FTIR, and a similar trend of crystallinity was also observed from XRD analysis. NC-32 was obtained with the highest yield of 94.83 %, followed by 91.40 % and 81.70 % for NC-48 and NC-64, respectively, whereas NC-72 yielded the lowest yield of 12.03 %. NC-72 had the highest thermal stability among other NC morphologies.

PMID:37660858 | DOI:10.1016/j.ijbiomac.2023.126657

https://pubmed.ncbi.nlm.nih.gov/37660858/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230904190707&v=2.17.9.post6+86293ac September 3, 2023 10:00 am

PubMed: An overview on synthetic and biological activities of cannabidiol (CBD) and its derivatives

PubMed: An overview on synthetic and biological activities of cannabidiol (CBD) and its derivatives

Bioorg Chem. 2023 Aug 25;140:106810. doi: 10.1016/j.bioorg.2023.106810. Online ahead of print.

ABSTRACT

(-)-Cannabidiol is a class of non-psychoactive plant cannabinoids derived from cannabis plants. Currently, Epidiolex (Cannabidiol) has been approved by the FDA for the treatment of two rare and severe forms of epilepsy related diseases, namely Lennox-Gastaut syndrome (LGS) and Dravet (DS). In addition, Cannabidiol and its structural analogues have received increasing attention due to their potential therapeutic effects such as neuroprotection, anti-epilepsy, anti-inflammation, anti-anxiety, and anti-cancer. Based on literature review, no comprehensive reviews on the synthesis of Cannabidiol and its derivatives have been found in recent years. Therefore, this article summarizes the published synthesis methods of Cannabidiol and the synthesis routes of Cannabidiol derivatives, and introduces the biological activities of some Cannabidiol analogues that have been studied extensively and have significant activities.

PMID:37659147 | DOI:10.1016/j.bioorg.2023.106810

https://pubmed.ncbi.nlm.nih.gov/37659147/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230904190707&v=2.17.9.post6+86293ac September 2, 2023 10:00 am

PubMed: Quantification of (9R)- and (9S)-hexahydrocannabinol (HHC) via GC-MS in serum/plasma samples from drivers suspected of cannabis consumption and immunological detection of HHC and related substances in serum, urine, and saliva

PubMed: Quantification of (9R)- and (9S)-hexahydrocannabinol (HHC) via GC-MS in serum/plasma samples from drivers suspected of cannabis consumption and immunological detection of HHC and related substances in serum, urine, and saliva

Drug Test Anal. 2023 Aug 31. doi: 10.1002/dta.3570. Online ahead of print.

ABSTRACT

The semisynthetic cannabinoid hexahydrocannabinol (HHC) is currently getting a lot of media attention because the legal status in many countries is not clearly specified. In this study, a GC-MS method for the quantification of Δ9-tetrahydrocannabinol (THC), 11-hydroxy-Δ9-tetrahydrocannabinol (11-OH-THC), and 11-nor-9-carboxy-Δ9-tetrahydrocannabinol (THC-COOH) was extended to (9R)- and (9S)-HHC. The applicability was proven by serum/plasma samples from drivers suspected of cannabis consumption. Limit of detection (LOD) and lower limit of quantification (LLOQ) were 0.15 and 0.25 ng/mL, respectively. Within-run imprecision was <6.5% and between-run imprecision was <10.0%. Inter-injection stability, processed sample stability (3 days), freeze-thaw stability (three cycles), and storage stability (1 week room temperature; 1 month 4°C, -20°C) could be proven. Both HHC diastereomers could be detected in 17 (5.3%) out of 321 analyzed samples from traffic controls in Western Saxony. The mean ratio between (9R)- and (9S)-HHC was 1.99 (CV = 14.6%). Quantification resulted in concentrations between <LLOQ and 35.35 ng/mL for (9R)-HHC and <LLOQ and 21.76 ng/mL for (9S)-HHC. Additionally, cross-reactivities of HHC, 11-hydroxy-hexahydrocannabinol (11-OH-HHC), 11-nor-9-carboxy-hexahydrocannabinol (HHC-COOH), hexahydrocannabiphorol (HHC-P), hexahydrocannabinol acetate (HHC-O), and tetrahydrocannabidiol (H4-CBD) were evaluated in five immunological screening tests for serum, urine, and saliva. Urine test strips and ELISA tests for the detection in serum seem to be beneficial to detect HHC consumption in comparison with saliva tests. HHC analogs and H4-CBD showed no cross-reactivity with any of the tests.

PMID:37652872 | DOI:10.1002/dta.3570

https://pubmed.ncbi.nlm.nih.gov/37652872/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230901190622&v=2.17.9.post6+86293ac August 31, 2023 10:00 am

PubMed: Cannabidiol acts as molecular switch in innate immune cells to promote the biosynthesis of inflammation-resolving lipid mediators

PubMed: Cannabidiol acts as molecular switch in innate immune cells to promote the biosynthesis of inflammation-resolving lipid mediators

Cell Chem Biol. 2023 Aug 21:S2451-9456(23)00249-0. doi: 10.1016/j.chembiol.2023.08.001. Online ahead of print.

ABSTRACT

Cannabinoids are phytochemicals from cannabis with anti-inflammatory actions in immune cells. Lipid mediators (LM), produced from polyunsaturated fatty acids (PUFA), are potent regulators of the immune response and impact all stages of inflammation. How cannabinoids influence LM biosynthetic networks is unknown. Here, we reveal cannabidiol (CBD) as a potent LM class-switching agent that stimulates the production of specialized pro-resolving mediators (SPMs) but suppresses pro-inflammatory eicosanoid biosynthesis. Detailed metabololipidomics analysis in human monocyte-derived macrophages showed that CBD (i) upregulates exotoxin-stimulated generation of SPMs, (ii) suppresses 5-lipoxygenase (LOX)-mediated leukotriene production, and (iii) strongly induces SPM and 12/15-LOX product formation in resting cells by stimulation of phospholipase A2-dependent PUFA release and through Ca2+-independent, allosteric 15-LOX-1 activation. Finally, in zymosan-induced murine peritonitis, CBD increased SPM and 12/15-LOX products and suppressed pro-inflammatory eicosanoid levels in vivo. Switching eicosanoid to SPM production is a plausible mode of action of CBD and a promising inflammation-resolving strategy.

PMID:37647900 | DOI:10.1016/j.chembiol.2023.08.001

https://pubmed.ncbi.nlm.nih.gov/37647900/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230831190609&v=2.17.9.post6+86293ac August 30, 2023 10:00 am

PubMed: Quality and safety of hemp meal as a protein supplement for nonlactating dairy cows

PubMed: Quality and safety of hemp meal as a protein supplement for nonlactating dairy cows

J Dairy Sci. 2023 Aug 23:S0022-0302(23)00482-4. doi: 10.3168/jds.2023-23222. Online ahead of print.

ABSTRACT

Hemp seed meal may be a suitable protein supplement for dairy cows, but its quality and safety as a dairy cow feed has not yet been fully investigated. As a result, dry matter intake (DMI), rumen fermentation, blood metabolites, total-tract digestibility, and concentrations of cannabinoids in blood plasma, urine, muscle, and adipose tissues were compared among nonlactating Holstein dairy cows receiving a basal partial mixed ration that was supplemented with either 10.2% dry matter (DM) hemp meal (HM treatment), 13.5% DM canola meal (CM treatment), or 6.25% DM hemp meal and 6.16% DM canola meal (HC treatment). Diets were formulated to be isoenergetic and isonitrogenous. Six nonlactating, nonpregnant Holstein cows were used in a repeated 3 × 3 Latin square design trial with three 3-wk experimental periods. The first 2 weeks of each served as adaptation. Sample and data collection occurred during the third week of each period. Neither the partial mixed ration nor canola meal contain cannabidiol (CBD), cannabidiolic acid (CBDA), d9-tetrahydrocannabinol (THC), or tetrahydrocannabinolic acid A (THCA-A). However, the hemp meal contained 3.0, 4.4, 0, and 0.1 μg/g DM of CBD, CBDA, THC, and THCA-A, respectively. Treatment did not affect DMI, pH, concentrations of volatile fatty acids or ammonia in the rumen, total-tract digestibilities of DM and crude protein, or blood plasma concentrations of glucose, urea, β-hydroxybutyrate, and nonesterified fatty acids. Hence, based on these metabolites, treatment did not affect the nutritional status of the cows. However, the total-tract neutral detergent fiber digestibility of the CM treatment (43%) was higher than that of the HM treatment (38%). No cannabinoids were detected in blood plasma, rumen fluid, and urine. Cannabinoids were also not detected in kidney, liver, urine, muscle, or adipose tissues at the end of the experiment when cows had undergone all treatments. Feces from all treatments did not contain detectable concentrations of THC or THCA-A, but feces of cows on the HC treatment contained 0.42 and 0.40 μg/g DM of CBD and CBDA, respectively. Feces of cows on the HM treatment contained 0.68 and 0.67 μg/g DM of CBD and CBDA, respectively. This indicated that most ingested CBD and CBDA were not absorbed but instead were excreted in the feces. Our data show dietary inclusion rates of up to 10.2% of DM. We find that hemp meal is a high-quality and safe protein supplement for nonlactating dairy cows.

PMID:37641272 | DOI:10.3168/jds.2023-23222

https://pubmed.ncbi.nlm.nih.gov/37641272/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230829190555&v=2.17.9.post6+86293ac August 29, 2023 10:00 am

Marijuana or Cannabis

Marijuana or Cannabis

What do we call the drug?

Here’s the first jurisdiction to tax our subject:

British Indian colonizers used “hemp drugs” generally, ganja and bhang and more for different products, cannabis rarely, and only for the plant (marijuana not at all): 

https://digital.nls.uk/indiapapers/browse/archive/74574106

https://nida.nih.gov/publications/drugfacts/cannabis-marijuana:

Marijuana refers to the dried leaves, flowers, stems, and seeds from the Cannabis sativa or Cannabis indica plant.

https://www.dea.gov/sites/default/files/2020-06/Marijuana-Cannabis-2020_0.pdf:

Marijuana is a mind-altering (psychoactive)
drug, produced by the Cannabis sativa plant. 

Beyond official federal sources, there are lots of opinions.  I googled marijuana or cannabis – and I may slant what I found toward marijuana.

https://www.theguardian.com/society/2018/jan/29/marijuana-name-cannabis-racism:

Harborside, which is among the oldest and largest dispensaries in California, says on its website: “‘Marijuana’ has come to be associated with the idea that cannabis is a dangerous and addictive intoxicant, not a holistic, herbal medicine … This stigma has played a big part in stymying cannabis legalization efforts throughout the US.”

It’s clear why a business like Harborside would prefer the more scientific word for branding purposes, but does that mean everyone should follow along?

https://www.leafly.com/news/politics/is-the-word-marijuana-racist:

(I know the author, who is at the top of hemp drug journalism — I recommend the whold article)

Queen Adesuyi, senior national policy manager for the Drug Policy Alliance, brought up another aspect of marijuana usage. That is: Labeling marijuana as racist or offensive may alienate many of the people most connected to the plant—and those disproportionately targeted by the War on Drugs.

“The word cannabis is very disconnected to most communities,” she said. “Your average person does not refer to the plant as cannabis.”

“As we’re working to advance legalization across the country, what we don’t want is a complete whitewashing of the history of marijuana criminalization and the impact that’s had on people of color,” Adesuyi added. “This is something we’re seeing the industry do. There’s an active attempt to revamp what the plant means, and who it represents.”

“When you think about ‘the new face of cannabis’” presented by some companies, she said, “it oftentimes is not in alignment with [those most affected by] the stigmatized and criminalized history of the plant.”

There’s also the question of political focus and wasted resources. “It’s important to lead the public discussion about the terms we use,” said Calvin Stovall, Leafly’s East Coast editor, “but I don’t think it’s productive to police how consumers or other members of the industry use the word marijuana.

“I’d rather see us direct our collective energy at the institutional level—to change the laws that are racist and offensive. Forcing people to take a political stance by only saying cannabis and never marijuana creates a dynamic where the legalization community gets caught up arguing among ourselves about terminology.”

Decision time in Word Court

After weeks of conversation and rumination, I find myself disagreeing with Rep. Melanie Morgan.

Let me say it clearly: Marijuana is not pejorative or racist.

The impulse that drove Morgan to change the language of Washington State law wasn’t unfounded, though. It’s time to update the legal conversation to cannabis. But Morgan’s diagnosis was imprecise and too simplistic. Marijuana is a problematic, complicated word with a problematic, complicated history. In the year 2022 it exists in a state of flux, loathed by some while used without malice by many.

Thriving in the cannabis world requires flexibility and quick adaptive reflexes. The language we use reflects that. We’re constantly reading the room to determine the appropriate verbiage. Mostly it’s cannabis or marijuana, but now and then it’s weed and sometimes it’s pot. Sometimes it can feel like living in a Key & Peele code-switch sketch.

That’s my answer today. Stay tuned. It’ll probably change, because language never stops evolving and neither should we.

https://www.kuow.org/stories/stop-using-the-word-marijuana-some-lawmakers-think-so:

Stop saying ‘marijuana’? Lawmakers say it’s racist

David Hyde

March 31, 2022 / 11:55 am

caption: Chelsea Stenson trims marijuana buds before packaging  on Wednesday, July 18, 2018, at House of Cultivar in Seattle.

Chelsea Stenson trims marijuana buds before packaging on Wednesday, July 18, 2018, at House of Cultivar in Seattle. 

KUOW Photo/Megan Farmer

PLAYING5 MINS LEFT

Gov. Jay Inslee recently signed a bill striking the word “marijuana” from the text of all state law. The measure says to use the word “cannabis” instead.

The effort in Washington is part of a national movement to retire the word.

Washington Democrat Melanie Morgan, who sponsored the bill in the state House, calls the word marijuana “pejorative and racist.” Morgan said replacing it is merely one way to create change.

Some cannabis retailers and industry trade groups have stopped using the word. Earlier this year, Maine and Virginia also introduced bills about striking the word marijuana from their laws.

Recreational weed is now legal in these states. But lawmakers are seeking to address the ways that decades of anti-drug policies continue to affect communities of color. For instance, arrests and incarceration for drug crimes have hit Black and Latino communities hardest. Arrests can make it harder to find a job, buy a home and build generational wealth.

“This is just another layer, of peeling off the systemic racism that’s built in our system,” Morgan said of the effort to retire the word marijuana.

But some historians are raising concerns about this effort. They say those who support it are leaning too heavily on a version of cannabis history that’s seeped into popular culture. They say that Morgan and other reformers who point to racist usage of the word have based that assessment on an incomplete reading of cannabis history.

The marijuana story

Historians note that “marijuana” was the word most people in Mexico used for the drug cannabis by the 19th century. Here in the U.S., by the 1920s and ’30s, anti-drug crusaders spread false claims about the effects of smoking marijuana. The 1936 movie “Reefer Madness” famously repeated this misinformation, claiming weed-smoking led to murder, suicide and insanity.

 Anti-drug activists often used the word marijuana in a negative way, and the media and government officials also turned it against people of color, including Mexican immigrants and jazz musicians. Then, in 1937, the federal government outlawed the drug.

That popularized narrative is part of why many now say the word marijuana should be retired. But historians KUOW spoke with believe the popular version of cannabis history is incomplete, and ultimately inaccurate.

“The idea that the word marijuana is racist, I just think it’s nonsense. Marijuana is just the Mexican word for drug cannabis,” said Isaac Campos, a professor of Latin American history who has studied the story of weed.

The making of a myth

Campos said stories about smoking marijuana leading to madness and violence didn’t originate in the U.S. They were first printed in Mexican newspapers, and it was the Mexican government that ended up outlawing the drug first — nearly 20 years before the U.S. did.

U.S. media reprinted anti-weed stories from the Mexican press. And as immigrants moved north, many carried negative stories about marijuana with them.

According to Campos, the more complete story of the word marijuana is a story about the influence of Mexican culture. He believes banning the word would erase that history.

Campos doesn’t deny that racists have sometimes used the word marijuana in a pejorative way. But he argues many other words, such as “salsa,” have also been used in racist ways without anyone calling for their retirement.

“The way we use the word marijuana in the United States is not unlike the way we use the word salsa in the United States. Salsa in Mexico just means ‘sauce.’ It’s any kind of sauce — it could be a Hollandaise sauce — it’s not necessarily what we call salsa in this country. 

“But the fact that we use it for a certain kind of Mexican sauce that goes on tacos just shows that Mexican cuisine has had a huge influence in this country,” Campos said.

Another cannabis historian, Adam Rathge, said something else is missing from pop-culture histories of weed. Long before anyone in the U.S. linked Mexican immigrants with the word marijuana, doctors and lawmakers in America were raising concerns about consuming cannabis.

“If you read 19th century medical journals or if you go look at laws that are passed in the 19th century, at the state level, there’s immediate concern by American physicians about the potential negative effects of cannabis,” Rathge said.

But that story was forgotten. In its place, by the 1980s, the cannabis legalization movement instead preferred a partially made-up narrative, based largely on an influential book written by a pot legalization activist named Jack Herer, who claimed America had a simple love affair with hemp and cannabis before racist prohibition began.

The film “Dazed and Confused” satirized this version of history, with tales of George Washington smoking weed with Martha Washington’s assistance, back when the “whole country” was supposedly “getting high.”

 For her part, Rep. Melanie Morgan stands by the new measure nixing the word marijuana from state law. But she also said she welcomes more information and debate about the linguistic history of the word.

“I’m glad that this is causing conversations, because what this is doing is actually opening the door to bigger issues,” Morgan said.

Morgan pointed to other bills to address structural racism that did not pass this legislative session, including an attempt to increase the number of cannabis businesses licenses that go to communities most affected by the war on drugs, and a bill she sponsored to address racial, economic and social disparities.

The measure striking the word marijuana from Washington state law starts to go into effect this coming June.


#CBD #Hemp

Marijuana or Cannabis


August 28, 2023 10:58 pm

The CBD Regulatory Environment in Europe: Part 2

The CBD Regulatory Environment in Europe: Part 2

This is Part Two of a four-part series discussing European cannabis regulations. Click here for Part One. Part Two analyzes the differences between the UK, the EU and the US. Part Three, coming next week, dives into dosage, approvals and more. Stay tuned for more.


EU Regulatory Environment

We Europeans look with envy at the American market and wonder, why can’t we be more like that? The differences between the American market, the UK and the EU economic zone couldn’t be more different, but changes seem to be on the horizon. While both the UK and the EU apply the Novel Food law, implementation varies significantly.

In the EU, applications are submitted to the EU Commission, and approval can take up to nine months – just for approval of the application – not the testing that will follow. And while the application carries no fee, collecting the required data just to make the application can be expensive, and can run into six figures or higher. Once the application is approved, there may still be data gaps and uncertainties, with toxicology testing that can take years to complete, and ultimately must be approved and validated by EFSA (European Food Safety Authority). The required toxicology testing is where things get really expensive, with both the EIHA (European Industrial Hemp Association) and EFSA estimating costs around €3.5 million.

The EFSA’s Panel on Nutrition, Novel Foods and Food Allergens (NDA) has received 19 applications thus far for CBD as a novel food, with more in the pipeline. According to their website, NDA chair Prof. Dominique Turck reported that they “have identified several hazards related to CBD intake” and that many data gaps need filling before evaluations can go ahead. However, she concluded, “It is important to stress that we have not concluded that CBD is unsafe as food.”

As always, with food and drug reviews, it is up to the applicant to prove that a product is safe for human consumption. And for the EU Commission, EFSA is conclusive. And while initial testing is with animals, it also includes human testing, which helps explain the high cost.

At present, the EFSA has been unconvinced by the applications submitted so far, and seeks more data regarding the effect of CBD on the liver, gastrointestinal tract, endocrine system, nervous system and on people’s psychological well-being, as well as the impact on human reproduction.

Thus, in 2019, the EIHA formed a German corporation, the “EIHA projects GmbH”, formed for the purpose of pooling partners money to pay for the application and toxicity testing. The Novel Food applications (NFAs) for CBD isolate and synthetic CBD were submitted on November 4, 2022 and full spectrum will follow in April/May of 2023. It should be noted that the application for synthetic CBD has been completely dropped as no testing was ever preformed.

The applications must be reinforced by a series of tox studies under the auspices of the EFSA and for the UK, the FSA. The EFSA will start the risk assessment as soon as the suitability check is performed. The suitability check is a process performed by EFSA to make sure that they have enough data to perform the risk assessment. According to their webpage, the risk assessment can take nine months.

In the case of the application put forth by the EIHA projects GmbH, the CBD isolate dossier will be submitted to the EFSA in September and enter the risk assessment phase. In this phase, the EFSA will go over the data and can ask for more data, should they feel it necessary. They are allowed 9 months to complete this task and submit their recommendations to the EU commission for a 27-member vote, whereby the EIHA projects GmbH application will be valid and legally binding. The EIHA projects GmbH is expecting a validation during the course of 2024. This is a huge game changer!

The application for Full Spectrum distillate should be readied by the end of 2023, whereby the EFSA should be finished with the risk assessment near the end 2024. As Full Spectrum takes into account minor cannabinoid as well as limited THC, it is more complex. It should be noted, that testing full spectrum distillate with a 0.2% THC limit, tests the limit for how much THC can be ingested by humans without side effects. This study is unprecedented and might well have an enormous impact on the issue of THC and its possible future legalization. It is also costing a further one million euros to bring to fruition.

The UK Regulatory Approach

The UK Novel Food approach differs greatly from the EU’s, which has both strengths and weaknesses. What makes the UK CBD market so robust is that the FSA allows products to be sold as long as they were on the market prior to February 13, 2020 and are linked to applications submitted before March 31, 2021. As a result, the FSA was flooded with applications – many later denied on technical grounds, in great part because they didn’t meet these terms. Currently, some 11,000 products worth a projected 1 billion GBP in revenue remain on the FSA list, having passed pre-validation while the FSA awaits the final toxicology report. Only 400 CBD products have been culled from the list, but to date, not a single application has yet been approved. Pre-validation status is incumbent upon a toxicology report, and it remains to be seen how many companies are able to produce such a report.

Important to note is that due to Brexit, a UK validation when it does come, will not be valid in the EU, but products with an EU application accepted on the Union list will be valid in the UK.

UKflagStill with a projected 1 billion GBP at stake, it is easy to why UK CBD manufacturers work to appease the FSA despite the regulatory hurdles. By keeping the door open, the UK has managed to keep investors interested in the CBD market and the public safe from unmonitored products.

This is certainly not the case in the EU, where despite a smattering of products still ducking the authorities, the EU market remains thin by comparison. Their approach has stymied growth compared to the UK where robust Novel Food regulation is in place, but approached differently.

At present, a market comparison of the EU to the UK or North America seems bleak, at least for now, but following approval, future EU-wide distribution could be highly profitable. As we inch closer to a Novel Food listing, the European market may yet prove to be one of the largest markets for the safest CBD products in the world.

The American Market

Still, it is the American market that makes our mouth water; where oils, tinctures, candies, cakes, and drinks with every cannabinoid from CBD to Delta 9, Delta 8, and HHC are available and producers are on their way to becoming millionaires. With a market currently estimated at $6 billion, forecasts reach upwards of $16 billion by 2026.

FDAlogoAnd the health-related concerns, the testing requirements? Are these limited to the UK and the EU? Let’s take a closer look! A mood of caution is emerging in the American cannabis market, that includes producers and lawmakers alike, who are pushing for stricter laws and enforcement.

In America, the FDA (Food and Drug Administration) has alerted the public to CBD’s potential harmful side effects on their website and hope to force congress to deal with the issue.

Many of their concerns validate those of the FSA and the EFSA. For example: on their website the FDA makes a reference to only one CBD product that has been approved: a medicine called Epidiolex. The FDA cites the review of the Epidiolex’s application in 2018 when they identified certain safety risks, including potential for liver damage. The EFSA requires testing on the same issue.

The post The CBD Regulatory Environment in Europe: Part 2 appeared first on Cannabis Industry Journal.


#CBD #Hemp

The CBD Regulatory Environment in Europe: Part 2


August 28, 2023 7:03 pm

PubMed: Mining the chemical diversity of the hemp seed (<em>Cannabis sativa</em> L.) metabolome: discovery of a new molecular family widely distributed across hemp

PubMed: Mining the chemical diversity of the hemp seed (<em>Cannabis sativa</em> L.) metabolome: discovery of a new molecular family widely distributed across hemp

Front Plant Sci. 2023 Aug 10;14:1114398. doi: 10.3389/fpls.2023.1114398. eCollection 2023.

ABSTRACT

Hemp (Cannabis sativa L.) is a widely researched industrial crop with a variety of applications in the pharmaceutical, nutraceutical, food, cosmetic, textile, and materials industries. Although many of these applications are related to its chemical composition, the chemical diversity of the hemp metabolome has not been explored in detail and new metabolites with unknown properties are likely to be discovered. In the current study, we explored the chemical diversity of the hemp seed metabolome through an untargeted metabolomic study of 52 germplasm accessions to 1) identify new metabolites and 2) link the presence of biologically important molecules to specific accessions on which to focus on in future studies. Multivariate analysis of mass spectral data demonstrated large variability of the polar chemistry profile between accessions. Five main groups were annotated based on their similar metabolic fingerprints. The investigation also led to the discovery of a new compound and four structural analogues, belonging to a previously unknown chemical class in hemp seeds: cinnamic acid glycosyl sulphates. Although variability in the fatty acid profiles was not as marked as the polar components, some accessions had a higher yield of fatty acids, and variation in the ratio of linoleic acid to α-linolenic acid was also observed, with some varieties closer to 3:1 (reported as optimal for human nutrition). We found that that cinnamic acid amides and lignanamides, the main chemical classes of bioactive metabolites in hemp seed, were more concentrated in the Spanish accession Kongo Hanf (CAN58) and the French accession CAN37, while the Italian cultivar Eletta Campana (CAN48) demonstrated the greatest yield of fatty acids. Our results indicate that the high variability of bioactive and novel metabolites across the studied hemp seed accessions may influence claims associated with their commercialization and inform breeding programs in cultivar development.

PMID:37636102 | PMC:PMC10449600 | DOI:10.3389/fpls.2023.1114398

https://pubmed.ncbi.nlm.nih.gov/37636102/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230828190622&v=2.17.9.post6+86293ac August 28, 2023 10:00 am

PubMed: Cultivar-dependent phenotypic and chemotypic responses of drug-type <em>Cannabis sativa</em> L. to polyploidization

PubMed: Cultivar-dependent phenotypic and chemotypic responses of drug-type <em>Cannabis sativa</em> L. to polyploidization

Front Plant Sci. 2023 Aug 11;14:1233191. doi: 10.3389/fpls.2023.1233191. eCollection 2023.

ABSTRACT

Cannabis sativa L. is a plant with a wide range of potential medicinal applications. In recent years, polyploidy has gained attention as a potential strategy for rapidly improving C. sativa, which, unlike other modern crops, has not yet benefitted from this established biotechnological application. Currently, no reports on high THCA and CBDA drug-type polyploid cultivars have been published. Moreover, it still needs to be clarified if different cultivars react similarly to polyploidization. For these reasons, we set out to evaluate and compare the phenotype and chemotype of three high Δ9-tetrahydrocannabinolic acid (THCA) and one high cannabidiolic acid (CBDA) drug-type cultivars in their diploid, triploid and tetraploid state through agronomic and metabolomic approaches. Our observations on plant morphology revealed a significant increase in plant height and leaf size with increasing ploidy levels in a cultivar-dependent manner. In contrast, cannabinoids were negatively affected by polyploidization, with the concentration of total cannabinoids, THCA, CBDA and cannabigerolic acid (CBGA) decreasing significantly in higher ploidy levels across all four cultivars. Headspace analysis of volatiles revealed that total volatile content decreased in triploids. On the other hand, tetraploids reacted differently depending on the cultivars. Two THCA dominant cultivars showed an increase in concentrations, while in the other two cultivars, concentrations decreased. Additionally, several rare compounds not present in diploids appeared in higher ploidy levels. Moreover, in one high THCA cultivar, a couple of elite tetraploid genotypes for cannabinoid and volatile production were identified, highlighting the role of cultivar and genotypic variability as an important factor in Cannabis sativa L. polyploids. Overall, our observations on plant morphology align with the giga phenotype observed in polyploids of other plant species. The decrease in cannabinoids and volatiles production in triploids have relevant implications regarding their commercial use. On the other hand, this study found that tetraploidization is a suitable approach to improve Cannabis sativa L. medicinal potential, although the response is cultivar and genotype-dependent. This work lays the ground for further improving, evaluating and harnessing Cannabis sativa L. chemical diversity by the breeding, biotechnological and pharmaceutical sectors.

PMID:37636092 | PMC:PMC10455935 | DOI:10.3389/fpls.2023.1233191

https://pubmed.ncbi.nlm.nih.gov/37636092/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230828190622&v=2.17.9.post6+86293ac August 28, 2023 10:00 am

PubMed: Simultaneous Determination of Posaconazole and Hemp Seed Oil in Nanomicelles through RP-HPLC via a Quality-by-Design Approach

PubMed: Simultaneous Determination of Posaconazole and Hemp Seed Oil in Nanomicelles through RP-HPLC via a Quality-by-Design Approach

ACS Omega. 2023 Aug 11;8(33):30057-30067. doi: 10.1021/acsomega.3c02097. eCollection 2023 Aug 22.

ABSTRACT

The present study involves the development of a reverse-phase HPLC method employing the quality-by-design methodology for the estimation of posaconazole and hemp seed oil simultaneously in nanomicelles formulation. The successful separation of posaconazole and hemp seed oil was achieved together, and this is the first study to develop and quantify posaconazole and hemp seed oil nanomicelles with linoleic acid as the internal standard and developed a dual drug analytical method employing a quality-by-design approach. The study was performed on a Shimadzu Prominence-I LC-2030C 3D Plus HPLC system with a PDA detector and the Shim-pack Solar C8 column (250 mm × 4.6 mm × 5 μm) for analysis with a mobile phase ratio of methanol:water (80:20% v/v) maintaining the flow rate of 1.0 mL/min. The final wavelength was selected as 240 nm and the elution of hemp seed oil and posaconazole was obtained at 2.7 and 4.6 min, respectively, with a maximum run time of 8.0 min. Box Behnken design was employed to optimize the method, keeping the retention time, peak area, and theoretical plates as dependent variables, while the mobile phase composition, flow rate, and wavelengths were chosen as independent variables. Parameters such as specificity, accuracy, robustness, linearity, sensitivity, precision, ruggedness, and forced degradation study were performed to validate the method. The calibration curves of posaconazole and hemp seed oil were determined to be linear throughout the range for concentration. The suggested approach can be effectively utilized for estimating the content of drugs from their nanoformulation and proved suitable for both in vivo and in vitro research.

PMID:37636934 | PMC:PMC10448652 | DOI:10.1021/acsomega.3c02097

https://pubmed.ncbi.nlm.nih.gov/37636934/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230828190622&v=2.17.9.post6+86293ac August 28, 2023 10:00 am

PubMed: Cannabidiol safety considerations: Development of a potential acceptable daily intake value and recommended upper intake limits for dietary supplement use

PubMed: Cannabidiol safety considerations: Development of a potential acceptable daily intake value and recommended upper intake limits for dietary supplement use

Regul Toxicol Pharmacol. 2023 Aug 25:105482. doi: 10.1016/j.yrtph.2023.105482. Online ahead of print.

ABSTRACT

Consumer use of hemp-derived products continues to rise, underscoring the need to establish evidence-based safety guidance. The present study sought to develop recommendations for oral upper intake limits of cannabidiol (CBD) isolate. Sufficiently robust and reliable data for this purpose were identified from published human clinical trials and guideline-compliant toxicity studies in animal models. Based on the metrics used in this assessment, a potential Acceptable Daily Intake (ADI) value of 0.43 mg/kg-bw/d (e.g., 30 mg/d for 70-kg adult) was determined for the general population based on liver effects in human studies. This value applies to the most sensitive subpopulations, including children, over a lifetime of exposure and from all sources, including food. For dietary supplements with adequate product labeling intended for use by healthy adults only, a potential Upper Intake Limit (UL) of 70 mg/d was determined based on reproductive effects in animals. For healthy adults, except those trying to conceive, or currently pregnant or lactating, a conservative dietary supplement UL of 100 mg/d was identified based on liver effects; however, as the target population excludes individuals at risk for liver injury, an alternative dietary supplement UL of 160 mg/d for this population can also be considered.

PMID:37634699 | DOI:10.1016/j.yrtph.2023.105482

https://pubmed.ncbi.nlm.nih.gov/37634699/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230828190622&v=2.17.9.post6+86293ac August 27, 2023 10:00 am

PubMed: Retarding Effect of Hemp Hurd Lixiviates on the Hydration of Hydraulic and CSA Cements

PubMed: Retarding Effect of Hemp Hurd Lixiviates on the Hydration of Hydraulic and CSA Cements

Materials (Basel). 2023 Aug 10;16(16):5561. doi: 10.3390/ma16165561.

ABSTRACT

Wood wool panels are widely used in the construction industry as sustainable cementitious composites, but there is a growing need to replace traditional Portland cement with a binder that has a lower embodied carbon footprint. In addition, the sustainability of these panels may face serious impediments if the required amount of wood for their production needs a harvest rate higher than the rate at which the tree sources reach maturity. One solution is to use the wooden part of fast-growing plants such as hemp. However, the compounds extracted from the mixture of plants and water are the main cause of the delay observed during the hydration process of hydraulic binders in these cementitious composites. The objective of this study is to evaluate the effect of bio-aggregate lixiviates (hemp hurd) on the hydration kinetics of calcium sulfoaluminate (CSA) cement as a low-embodied-carbon alternative to ordinary Portland cement (OPC). The isothermal calorimeter showed that the hemp hurd lixiviate caused a greater delay in GU’s hydration process than CSA’s. At a 5% concentration, the main hydration peak for GU cement emerged after 91 h, whereas for CSA cement, it appeared much earlier, at 2.5 h. XRD and TGA analysis showed that after 12 h of hydration, hydration products such as calcium silicate hydrates (C-S-H) and portlandite (CH) were not able to form on GU cement, indicating low hydration of silicate products. Moreover, at 5% concentration, the carbonation of ettringite was observed in CSA cement. The compressive strength values obtained from the mixes containing hemp hurd lixiviate consistently showed lower values compared to the reference samples prepared with distilled water. Furthermore, the CSA samples demonstrated superior compressive strength when compared to the GU samples. After 28 days of hydration, the compressive strength values for CSA cement were 36.7%, 63.5% and 71% higher than GU cement at a concentration of 0.5%, 2% and 5% hemp hurd lixiviate, respectively.

PMID:37629852 | DOI:10.3390/ma16165561

https://pubmed.ncbi.nlm.nih.gov/37629852/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies

PubMed: Real-World Evidence of Factors Affecting Cannabidiol Exposure in Children with Drug-Resistant Developmental and Epileptic Encephalopathies

Pharmaceutics. 2023 Aug 10;15(8):2120. doi: 10.3390/pharmaceutics15082120.

ABSTRACT

The identification of factors that affect cannabidiol (CBD) systemic exposure may aid in optimizing treatment efficacy and safety in clinical practice. In this study, we aimed to correlate CBD plasma concentrations at a steady state to demographic, clinical, and pharmacological characteristics as well as seizure frequency after the administration of a purified CBD oil solution in a real-world setting of children with drug-resistant developmental and epileptic encephalopathies (DEEs). Patients receiving oral CBD pharmaceutical products at maintenance were enrolled. Venous blood samples were drawn before the CBD morning dose, 12 h apart from the last evening dose (C0 or CBD trough concentration). A linear mixed-effect analysis was implemented to assess the correlation between C0 and clinical, laboratory, pharmacological, and lifestyle factors. Fifteen females and seven males with a median age of 12.8 years (ranging between 4.7 and 17.2) were included. The median CBD dose was 8.8 mg/kg/day (ranging between 2.6 and 22.5), and the CBD C0 median (range) was 48.2 ng/mL (3.5-366.3). The multivariate model showed a 109.6% increase in CBD C0 in patients with concomitant levothyroxine (β = 0.74 ± 0.1649, p < 0.001), 56.8% with food (β = 0.45 ± 0.1550, p < 0.01), and 116.0% after intake of a ketogenic diet (β = 0.77 ± 0.3141, p < 0.05). All patients included were responders without evidence of an association between C0 and response status. In children with DEEs, systemic concentrations of CBD may be significantly increased when co-administered with levothyroxine, food, or a ketogenic diet.

PMID:37631333 | DOI:10.3390/pharmaceutics15082120

https://pubmed.ncbi.nlm.nih.gov/37631333/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Etoricoxib-Cannabidiol Combo: Potential Role in Glioblastoma Treatment and Development of PLGA-Based Nanoparticles

PubMed: Etoricoxib-Cannabidiol Combo: Potential Role in Glioblastoma Treatment and Development of PLGA-Based Nanoparticles

Pharmaceutics. 2023 Aug 9;15(8):2104. doi: 10.3390/pharmaceutics15082104.

ABSTRACT

BACKGROUND: Glioblastoma (GBM) is the most frequently occurring primary malignant central nervous system tumor, with a poor prognosis and median survival below two years. Administration of a combination of non-steroidal anti-inflammatory drugs and natural compounds that exhibit a curative or prophylactic effect in cancer is a new approach to GBM treatment. This study aimed to investigate the synergistic antitumor activity of etoricoxib (ETO) and cannabidiol (CBD) in a GBM cell line model, and to develop poly(lactic-co-glycolic acid) (PLGA)-based nanoparticles (NPs) for these two substances.

METHODS: The activity of ETO+CBD was determined using the MTT test, cell-cycle distribution assay, and apoptosis analysis using two GBM cell lines, namely, T98G and U-138 MG. The PLGA-based NPs were developed using the emulsification and solvent evaporation method. Their physicochemical properties, such as shape, size, entrapment efficiency (EE%), in vitro drug release, and quality attributes, were determined using scanning electron microscopy, diffraction light scattering, high-performance liquid chromatography, infrared spectroscopy, and differential scanning calorimetry.

RESULTS: The combination of ETO and CBD reduced the viability of cells in a dose-dependent manner and induced apoptosis in both tested GBM cell lines. The developed method allowed for the preparation of ETO+CBD-NPs with a spherical shape, mean particle size (MPS) below 400 nm, zeta potential (ZP) values from -11 to -17.4 mV, polydispersity index (PDI) values in the range from 0.029 to 0.256, and sufficient EE% of both drugs (78.43% for CBD, 10.94% for ETO).

CONCLUSIONS: The combination of ETO and CBD is a promising adjuvant therapeutic in the treatment of GBM, and the prepared ETO+CBD-NPs exhibit a high potential for further pharmaceutical formulation development.

PMID:37631318 | DOI:10.3390/pharmaceutics15082104

https://pubmed.ncbi.nlm.nih.gov/37631318/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Molecular and Cellular Mechanisms of Action of Cannabidiol

PubMed: Molecular and Cellular Mechanisms of Action of Cannabidiol

Molecules. 2023 Aug 9;28(16):5980. doi: 10.3390/molecules28165980.

ABSTRACT

Cannabidiol (CBD) is the primary non-psychoactive chemical from Cannabis Sativa, a plant used for centuries for both recreational and medicinal purposes. CBD lacks the psychotropic effects of Δ9-tetrahydrocannabinol (Δ9-THC) and has shown great therapeutic potential. CBD exerts a wide spectrum of effects at a molecular, cellular, and organ level, affecting inflammation, oxidative damage, cell survival, pain, vasodilation, and excitability, among others, modifying many physiological and pathophysiological processes. There is evidence that CBD may be effective in treating several human disorders, like anxiety, chronic pain, psychiatric pathologies, cardiovascular diseases, and even cancer. Multiple cellular and pre-clinical studies using animal models of disease and several human trials have shown that CBD has an overall safe profile. In this review article, we summarize the pharmacokinetics data, the putative mechanisms of action of CBD, and the physiological effects reported in pre-clinical studies to give a comprehensive list of the findings and major effects attributed to this compound.

PMID:37630232 | DOI:10.3390/molecules28165980

https://pubmed.ncbi.nlm.nih.gov/37630232/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Cannabis-Based Medicine for Neuropathic Pain and Spasticity-A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

PubMed: Cannabis-Based Medicine for Neuropathic Pain and Spasticity-A Multicenter, Randomized, Double-Blinded, Placebo-Controlled Trial

Pharmaceuticals (Basel). 2023 Jul 28;16(8):1079. doi: 10.3390/ph16081079.

ABSTRACT

Patients with multiple sclerosis (MS) and spinal cord injury (SCI) commonly sustain central neuropathic pain (NP) and spasticity. Despite a lack of consistent evidence, cannabis-based medicine (CBM) has been suggested as a supplement treatment. We aimed to investigate the effect of CBM on NP and spasticity in patients with MS or SCI. We performed a randomized, double-blinded, placebo-controlled trial in Denmark. Patients aged ≥18 years with NP (intensity >3, ≤9 on a numerical rating scale (NRS0-10) and/or spasticity (>3 on NRS0-10) were randomized to treatment consisting of either delta-9-tetrahydrocannabinol (THC), cannabidiol (CBD), a combination of THC&CBD in maximum doses of 22.5 mg, 45 mg and 22.5/45 mg per day, respectively, or placebo. A baseline registration was performed before randomization. Treatment duration was six weeks followed by a one-week phaseout. Primary endpoints were the intensity of patient-reported NP and/or spasticity. Between February 2019 and December 2021, 134 patients were randomized (MS n = 119, SCI n = 15), where 32 were assigned to THC, 31 to CBD, 31 to THC&CBD, and 40 to placebo. No significant difference was found for: mean pain intensity (THC 0.42 (-0.54-1.38), CBD 0.45 (-0.47-1.38) and THC&CBD 0.16 (-0.75-1.08)), mean spasticity intensity (THC 0.24 (-0.67-1.45), CBD 0.46 (-0.74-1.65), and THC&CBD 0.10 (-1.18-1.39), secondary outcomes (patient global impression of change and quality of life), or any tertiary outcomes. We aimed to include 448 patients in the trial; however, due to COVID-19 and recruitment challenges, fewer were included. Nevertheless, in this four-arm parallel trial, no effect was found between placebo and active treatment with THC or CBD alone or in combination on NP or spasticity in patients with either MS or SCI. The trial was registered with the EU Clinical Trials Register EudraCT (2018-002315-98).

PMID:37630995 | DOI:10.3390/ph16081079

https://pubmed.ncbi.nlm.nih.gov/37630995/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Cinnamyl-Modified Polyglycidol/Poly(ε-Caprolactone) Block Copolymer Nanocarriers for Enhanced Encapsulation and Prolonged Release of Cannabidiol

PubMed: Cinnamyl-Modified Polyglycidol/Poly(ε-Caprolactone) Block Copolymer Nanocarriers for Enhanced Encapsulation and Prolonged Release of Cannabidiol

Pharmaceutics. 2023 Aug 13;15(8):2128. doi: 10.3390/pharmaceutics15082128.

ABSTRACT

The present study describes the development of novel block copolymer nanocarriers of the phytocannabinoid cannabidiol (CBD), designed to enhance the solubility of the drug in water while achieving high encapsulation efficiency and prolonged drug release. Firstly, a well-defined amphiphilic block copolymer consisting of two outer hydrophilic polyglycidol (PG) blocks and a middle hydrophobic block of poly(ε-caprolactone) bearing pendant cinnamyl moieties (P(CyCL-co-CL)) were synthesized by the click coupling reaction of PG-monoalkyne and P(CyCL-co-CL)-diazide functional macroreagents. A non-modified polyglycidol/poly(ε-caprolactone) amphiphilic block copolymer was obtained as a referent system. Micellar carriers based on the two block copolymers were formed via the solvent evaporation method and loaded with CBD following two different protocols-loading during micelle formation and loading into preformed micelles. The key parameters/characteristics of blank and CBD-loaded micelles such as size, size distribution, zeta potential, molar mass, critical micelle concentration, morphology, and encapsulation efficiency were determined by using dynamic and static multiangle and electrophoretic light scattering, transmission electron microscopy, and atomic force microscopy. Embedding CBD into the micellar carriers affected their hydrodynamic radii to some extent, while the spherical morphology of particles was not changed. The nanoformulation based on the copolymer bearing cinnamyl moieties possessed significantly higher encapsulation efficiency and a slower rate of drug release than the non-modified copolymer. The comparative assessment of the antiproliferative effect of micellar CBD vs. the free drug against the acute myeloid leukemia-derived HL-60 cell line and Sezary Syndrome HUT-78 demonstrated that the newly developed systems have pronounced antitumor activity.

PMID:37631342 | DOI:10.3390/pharmaceutics15082128

https://pubmed.ncbi.nlm.nih.gov/37631342/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am

PubMed: Effects of Terpenes on the Osteoarthritis Cytokine Profile by Modulation of IL-6: Double Face versus Dark Knight?

PubMed: Effects of Terpenes on the Osteoarthritis Cytokine Profile by Modulation of IL-6: Double Face versus Dark Knight?

Biology (Basel). 2023 Jul 28;12(8):1061. doi: 10.3390/biology12081061.

ABSTRACT

BACKGROUND: Hemp seed oil and terpenes are emerging as a dietary supplement and complementary therapy for patients suffering from knee osteoarthritis (KOA). However, the mechanisms and effects induced by these molecules on inflammatory cytokines are not yet fully understood. The aim of this study was to evaluate the changes in the cytokine IL-1β, IL-1α, IL-2, IL-6, and TNF-α levels from two oral hemp seed oil-based dietary supplements, of which only one included the addition of terpenes, in a population of KOA patients.

METHODS: Sera from venous blood samples were collected from thirty-eight patients who were divided into two subgroups. The control group underwent a 45-day treatment with a dietary supplement containing only hemp seed oil, while the treatment group assumed a hemp seed oil and terpene-based dietary supplement for the same number of days. A Bio-Plex Human Cytokine assay was performed by a customized human cytokine five-plex panel for IL-1β, IL-1α, IL-2, IL-6, and TNF-α. Patients were evaluated before the beginning of the treatment (T0) and soon after it (T1).

RESULTS: No measurable levels of IL-2 and TNF-α were found in any of the subjects. Low levels of IL-1β were found, which were significantly decreased in the treatment group. No change in IL-1α levels was observed, while treated patients had a significant increase in IL-6 levels.

CONCLUSIONS: Hemp seed oil and terpene treatment modified the IL-1β and IL-6 levels, counteracting KOA inflammation in this way. In this study, IL-6 revealed its new and alternative action, since it is traditionally known as a pro-inflammatory factor, but it recently has been found to have anti-inflammatory activity in the muscle-derived form, which is the one it assumes as a myokine when activated by terpenes.

PMID:37626947 | DOI:10.3390/biology12081061

https://pubmed.ncbi.nlm.nih.gov/37626947/?utm_source=Chrome&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1NqsX9BbHlDygQ8TcgAlJilHgPpiuKQtyIr–a3-xbLzPoB9xM&fc=20220928170152&ff=20230826190620&v=2.17.9.post6+86293ac August 26, 2023 10:00 am