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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August 2023 510(K) Clearances

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August 2023 510(K) Clearances

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Wed, 09/06/2023 – 10:58

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