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
