Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 53
- Latest Decision
- 2019-05-07
Clearances · page 17 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K190649 | FUJIFILM Endoscope Model EC-760S-V/L | Fujifilm Corporation | FDF | Class II | 2019-05-07 |
| K183577 | Medline Quick-Clear Wand | Medline Industries, Inc. | KNT | Class II | 2019-05-04 |
| K183188 | Flexible Sensor-Ureterorenoscopes BOA Vision EF, Flexible Sensor-Ureterorenoscopes COBRA Vision EF | Richard Wolf Medical Instruments Corporation | FGB | Class II | 2019-05-03 |
| K182231 | Brush Biopsy Set ; Deflectable Brush Biopsy Set | Cook Incorporated | FDX | Class II | 2019-05-01 |
| K190114 | Flexi-Seal PROTECT PLUS Fecal Management System (with ENFit Connector) | Convatec Limited | KNT | Class II | 2019-04-30 |
| K183540 | Oral/Enteral Syringes with ENFit connector (12 mL to 60 mL), Low Dose Tip Oral/Enteral Syringes with ENFit connector (1 mL to 6 mL) | Neomed, Inc. | PNR | Class II | 2019-04-30 |
| K190592 | YelloPort Elite Port Access System | Surgical Innovations Limited | GCJ | Class II | 2019-04-29 |
| K183146 | Ranfac Cartilage Biopsy Needle | Ranfac Corporation | KNW | Class II | 2019-04-25 |
| K181787 | Cediflo Enteral Feeding Tubes & Cediflo Junior Enteral Feeding Tubes | Cedic S.R.L. | PIF | Class II | 2019-04-25 |
| K182723 | Flexible HD Cysto-Urethroscope System | KARL STORZ Endoscopy-America, Inc. | FAJ | Class II | 2019-04-23 |
| K190621 | SB Knife/Short type, SB Knife/Standard type, SB Knife/Jr type, SB Knife/Jr type - Long | Sumitomo Bakelite Co., Ltd. | KNS | Class II | 2019-04-23 |
| K181971 | Bander Ureteral Diversion Stent Set, Dretler Ureteroscopy Stent Set | Cook Incorporated | FAD | Class II | 2019-04-23 |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor | Advanced Sterilization Products (Asp) | FEB | Class II | 2019-04-23 |
| K183192 | CapsoCam Plus (SV-3) | CapsoVision, Inc. | NEZ | Class II | 2019-04-19 |
| K190729 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | OWN | Class II | 2019-04-19 |
| K190788 | Disposable Standard Clamp | Standard Bariatrics | GCJ | Class II | 2019-04-18 |
| K182998 | Andorate Auxiliary Water Connector | Smartdata Suzhou Co., Ltd. | OCX | Class II | 2019-04-17 |
| K183428 | Avulsion Forceps | STERIS Corporation | KGE | Class II | 2019-04-16 |
| K183619 | Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device | Boston Scientific Corporation | FAE | Class II | 2019-04-16 |
| K181673 | Rigi10 Malleable Penile Prosthesis | Rigicon, Inc. | FAE | Class II | 2019-04-15 |
| K182828 | Medline ReNewal Reprocessed Carter-Thomason Needle Point Suture Passer | Surgical Instrument Service and Savings, Inc. | NLM | Class II | 2019-04-15 |
| DEN180060 | Plenity | Gelesis, Inc. | QFQ | Class II | 2019-04-12 |
| K181758 | ELRA Electrode | Starmed Co., Ltd. | KNS | Class II | 2019-04-11 |
| K183057 | PUMA-G System | Coaptech, LLC | KGC | Class II | 2019-04-10 |
| K190327 | ENConnect 40 mm Screw Cap to ENPlus Adapter | Cedic S.R.L. | PIF | Class II | 2019-04-09 |
| K190164 | CleverLock Guidewire Locking Device and Biopsy Cap | Olympus Surgical Technologies America | ODC | Class II | 2019-04-04 |
| K182836 | FUJIFILM Endoscope Model EG-740N | Fujifilm Corporation | FDS | Class II | 2019-04-02 |
| K183508 | Micro Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | KNT | Class II | 2019-03-29 |
| K182164 | Ecolab POU Water Filter Spray Outlet, Ecolab POU Water Filter Nozzle Outlet, Ecolab POU Water Filter Shower Wand | Ecolab, Inc. | NHV | Class II | 2019-03-29 |
| K190648 | Pusen Eview Medical Video Endoscope Image Processor | Zhuhai Pusen Medical Technology Co., Ltd. | FET | Class II | 2019-03-29 |
| K181745 | FUJIFILM Duodenoscope Model | Fujifilm Corporation | FDT | Class II | 2019-03-28 |
| K190093 | Rezum Delivery Device, Rezum Generator | Nxthera (A Boston Scientific Company) | KNS | Class II | 2019-03-25 |
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | 2019-03-25 |
| K181173 | ELMED Laparoscopic Instruments and Accessories | Elmed Incorporated | GCJ | Class II | 2019-03-22 |
| K190377 | UroLift System UL400 | Neotract, Inc. | PEW | Class II | 2019-03-21 |
| K182511 | SimplCath | F&S Medical Solutions, LLC | GBM | Class II | 2019-03-20 |
| K190099 | Veloxion Controller Kit, Veloxion Fluid Control Kit, Veloxion Resectoscope, Veloxion Video Control Unit, Veloxion Roll Stand, Waste Management Tubing, Tissue Catch | Corinth Medtech, Inc. | FJL | Class II | 2019-03-15 |
| K182022 | ApexMV | Incontrol Medical, LLC | KPI | Class II | 2019-03-15 |
| K182371 | da Vinci SP Surgical System, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | 2019-03-14 |
| K181669 | ConvertX Biliary Stent System | Brightwater Medical | FGE | Class II | 2019-03-14 |
| K183600 | Anchor Bag-Alone Tissue Retrieval System by ConMed | Conmed Corporation | GCJ | Class II | 2019-03-13 |
| K183289 | ClearGrasp Snare | Finemedix Co., Ltd. | FDI | Class II | 2019-03-06 |
| K183053 | Olympus Small Intestinal Capsule Endoscope System | Olympus Medical Systems Corp. | NEZ | Class II | 2019-03-05 |
| K190030 | Embrella Endoscopic Distal Attachment | Micro-Tech (Nanjing) Co., Ltd. | FED | Class II | 2019-03-05 |
| K183453 | VS3-IR | Medtronic | OWN | Class II | 2019-03-04 |
| K182804 | Traditional Length GJ Feeding Device | Applied Medical Technology, Inc. | KNT | Class II | 2019-03-01 |
| K183686 | FUJIFILM Endoscope Model EG-530N | Fujifilm Corporation | FDS | Class II | 2019-02-28 |
| K183683 | FUJIFILM Double Balloon Endoscopes EN-580T, EC-450BI5, EN-450P5/20, and EN-450T5 | Fujifilm Corporation | FDA | Class II | 2019-02-27 |
| K183640 | Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | 2019-02-22 |
| K183072 | EndoFLIP System | Crospon, Ltd. | FFX | Class II | 2019-02-15 |
| K182915 | ENvizion Medical ENvue; ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | KNT | Class II | 2019-02-13 |
| K183585 | Elitone Device | Elidah, Inc. | QAJ | Class II | 2019-02-11 |
| K183396 | HANAROSTENT FASTTM Biliary (NNN) | M.I.Tech Co., Ltd. | FGE | Class II | 2019-02-11 |
| K181317 | Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush | Wilson-Cook Medical, Inc. | FDX | Class II | 2019-02-08 |
| K182319 | Glo-Tip Spray Catheter | Wilson-Cook Medical, Inc. | OCX | Class II | 2019-02-01 |
| K182895 | Wilson-Cook Achalasia Balloon | Wilson-Cook Medical, Inc. | PID | Class II | 2019-01-25 |
| K183636 | SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller | Boston Scientific Corporation | FBN | Class II | 2019-01-22 |
| K181887 | AMD Anti-Fog Solution | Advanced Medical Design Co., Ltd. | OCT | Class II | 2019-01-22 |
| K181097 | Cook Cystostomy Catheter Set | Cook Incorporated | KOB | Class II | 2019-01-18 |
| K183264 | Flex-THOR scope | KARL STORZ Endoscopy-America, Inc. | GCJ | Class II | 2019-01-18 |
| K183224 | SureForm 45, SureForm 45 Reloads | Intuitive Surgical | NAY | Class II | 2019-01-18 |
| K181084 | PENTAX Video Colonoscopes (EC Family) | Pentax of America, Inc. | FDF | Class II | 2019-01-18 |
| K180236 | VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) | Vr Medical Technology Co., Ltd. | FPD | Class II | 2019-01-18 |
| K181451 | URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R | Olympus Medical Systems Corp. | FGB | Class II | 2019-01-16 |
| K180410 | Dosis SAM | Dosis, Inc. | MQS | Class II | 2019-01-16 |
| K182421 | Senhance Ultrasonic System | Transenterix, Inc. | NAY | Class II | 2019-01-11 |
| K182635 | Signal Catheter | Safe Medical Design | EZL | Class II | 2019-01-10 |
| K182367 | DIASAFEplusUS | Fresenius Medical Care Renal Therapies Group, LLC | FIP | Class II | 2019-01-10 |
| K182709 | One-Step Suprapubic Introducer | Cook Incorporated | KOB | Class II | 2018-12-26 |
| K181690 | Clear-Jet Injection Catheter | Finemedix Co., Ltd. | FBK | Class II | 2018-12-21 |
| DEN170021 | SEM Scanner (Model 200) | Bruin Biometrics, LLC | QEF | Class I | 2018-12-20 |
| K183253 | ValPro 2 Plus, VaPro 2 Plus Pocket | Hollister Incorporated | GBM | Class II | 2018-12-18 |
| K181756 | Gangi-SoftGuard Coaxial Needle, Gangi-HydroGuard Coaxial Needle | Apriomed AB | FCG | Class II | 2018-12-18 |
| K182556 | SureClip Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2018-12-14 |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid System | STERIS Corporation | FEB | Class II | 2018-12-14 |
| K182434 | LaparoGuard | Mariner Endosurgery, Inc. | GCJ | Class II | 2018-12-13 |
| K183107 | Intuitive Surgical Vessel Sealer Extend | Intuitive Surgical, Inc. | NAY | Class II | 2018-12-11 |
| K180679 | CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate) | Global Scientific Technologies, LLC | KPO | Class II | 2018-12-07 |
| K182664 | FiXcision | Agency For Medical Innovations GmbH | KOA | Class I | 2018-12-07 |
| K183098 | Senhance Surgical System | Transenterix, Inc. | NAY | Class II | 2018-12-06 |
| K173495 | Single Use Hot Biopsy Forceps FD-231 | Olympus Medical Systems Corp. | QEC | Class II | 2018-11-30 |
| K180557 | Greene Renal Transplant Stent Set | Cook Incorporated | FAD | Class II | 2018-11-23 |
| K182909 | Roth Net Retriever Product Line | United States Endoscopy Group, Inc. | FDI | Class II | 2018-11-21 |
| K182606 | PINPOINT Endoscopic Fluorescence Imaging System | Novadaq Technologies Ulc. (Now A Part of Stryker) | GCJ | Class II | 2018-11-21 |
| K182696 | Telepack X LED | KARL STORZ Endoscopy-America, Inc. | FET | Class II | 2018-11-20 |
| K181643 | SmartBag (SmartPouch) | 11 Health Technologies Limited | EXB | Class I | 2018-11-16 |
| K182980 | Zilver 518 Biliary Stent, Zilver 635 Biliary Stent | Cook Ireland, Ltd. | FGE | Class II | 2018-11-16 |
| K181750 | SITZMARKS | Konsyl Pharmaceuticals | FFX | Class II | 2018-11-15 |
| K180668 | Single Use Aspiration Needle NA-U401SX-4025/NA-U401SX-4025N | Olympus Medical Systems Corp. | FCG | Class II | 2018-11-15 |
| K181497 | HPM-6000UF | BTL Industries, Inc. | KPI | Class II | 2018-11-14 |
| K182248 | Aspire Venting Tube | Aspire Bariatrics, Inc. | KNT | Class II | 2018-11-13 |
| K182649 | Enteral Feeding Syringes with Enfit Connectors | Jiangsu Kangbao Medical Equipment Co., Ltd. | PNR | Class II | 2018-11-09 |
| K173917 | neoClose PDS | Neosurgical, Ltd. | GCJ | Class II | 2018-11-08 |
| K180732 | MiroCam Capsule Endoscope System | Intromedic Co., Ltd. | NEZ | Class II | 2018-11-08 |
| DEN170049 | Innovo | Bio-Medical Research, Ltd. | QAJ | Class II | 2018-11-06 |
| K180469 | ImaJin Silicone Hydro-Coated Double Loop Ureteral Stent | Coloplast Corp. | FAD | Class II | 2018-11-06 |
| K182444 | ERBEFLO Olympus Scope Port Connector | Erbe USA, Inc. | OCX | Class II | 2018-11-06 |
| K180801 | Actreen Hi-Lite Cath, Actreen Hi-Lite Set | B.Braun Medical, Inc. | GBM | Class II | 2018-11-05 |
| K182160 | 1688 Camera Control Unit ; 1688 AIM 4K Camera Head, C-Mount ; 1688 AIM 4K Camera Head with Integrated Coupler ; AIM 4K Coupler, 20mm, C-Mount ; L11 LED Light Source with AIM | Stryker | GCJ | Class II | 2018-11-05 |
| K181258 | ConnectedOR Hub with Device and Voice Control | Stryker | GCJ | Class II | 2018-11-05 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.