Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 54
- Latest Decision
- 2021-05-28
Clearances · page 13 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K211301 | Pathfinder Endoscope Overtube | Neptune Medical, Inc. | FED | Class II | 2021-05-28 |
| K210917 | Single Use Injection Needle | Anrei Medical (Hangzhou) Co., Ltd. | FBK | Class II | 2021-05-28 |
| K211282 | Aqua Medical RF Vapor System | Aqua Medical, Inc. | KNS | Class II | 2021-05-27 |
| K203322 | SpyGlass Discover Retrieval Basket | Boston Scientific Corporation | LQR | Class II | 2021-05-26 |
| K210915 | Pathfinder Endoscope Cap | Neptune Medical, Inc. | FDS | Class II | 2021-05-25 |
| K210476 | EchoTip Ultra Endoscopic Ultrasound Needle, EchoTip ProCore HD Ultrasound Biopsy Needle, EchoTip Ultra Endobronchial High Definition Ultrasound Needle, EchoTip ProCore Endobronchial High Definition Ultrasound Biopsy Needle | Cook Ireland, Ltd. | FCG | Class II | 2021-05-20 |
| K210394 | Electrosurgical accessory | Dornier Medtech America, Inc. | FAS | Class II | 2021-05-19 |
| K203226 | TELESCOPE 0 O 10MM WL 305MM / TELESCOPE 30 O 10MM WL 305MM / TELESCOPE 50 O 10MM WL 305MM, TELESCOPE 0 O 10MM WL 440MM / TELESCOPE 30 O 10MM WL 440MM / TELESCOPE 50 O 10MM WL 440MM | Richard Wolf Medical Instruments Corporation | GCM | Class II | 2021-05-14 |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | Pentax of America, Inc. | FDS | Class II | 2021-05-13 |
| K203566 | Tablet Application | Smith & Nephew | ODA | Class II | 2021-05-13 |
| K202973 | HANAROSTENT Benefit Biliary (NNN) | M.I.Tech Co., Ltd. | FGE | Class II | 2021-05-11 |
| K210353 | AutoCap RX | Boston Scientific Corporation | ODC | Class II | 2021-05-06 |
| K202921 | Uro-G Cystoscope | Uroviu Corporation | FAJ | Class II | 2021-05-04 |
| K203192 | NaviCam Xpress Stomach System | Anx Robotica Corp | QKZ | Class II | 2021-05-04 |
| K203165 | Disposable Ureteral Access Sheath | Suzhou Beyo Medical Technology Co., Ltd. | FED | Class II | 2021-04-30 |
| K210981 | Pure Vu System | Motus GI Medical Technologies , Ltd. | FDF | Class II | 2021-04-29 |
| K210621 | Oral/Enteral Syringe | Ningbo Tianyi Medical Appliance Co., Ltd. | PNR | Class II | 2021-04-28 |
| K211072 | Safety Trocar Cannula | Boston Scientific Corporation | KNT | Class II | 2021-04-27 |
| K210660 | Stone Retrieval Balloon Catheter | Anrei Medical (Hangzhou) Co., Ltd. | GCA | Class II | 2021-04-27 |
| K200260 | Percuflex Ureteral Stent System, Percuflex Ureteral Stent System Kit, Percuflex Nephroureteral Stent System, Amplatz Anchor Catheter System | Boston Scientific Corporation | FAD | Class II | 2021-04-26 |
| K210918 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | 2021-04-26 |
| K210851 | DiLumen Endolumenal Interventional Platform (DiLumen) | Lumendi, LLC | FDF | Class II | 2021-04-21 |
| K203276 | Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) | Biocompatibles UK Ltd (Part of Boston Scientific Corporation | NOY | Class II | 2021-04-20 |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | PCU | Class II | 2021-04-15 |
| K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes | Stryker | GCJ | Class II | 2021-04-13 |
| K202748 | Enteral Feeding Catheter | Medcaptain Life Science Co., Ltd. | KNT | Class II | 2021-04-09 |
| K210162 | Endoscope Model EI-740D/S | Fujifilm Corporation | FDS | Class II | 2021-04-09 |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | Pentax of America, Inc. | FDT | Class II | 2021-04-09 |
| DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | QNP | Class II | 2021-04-09 |
| K203550 | ActivSight Intraoperative Imaging System | Activ Surgical, Inc. | OWN | Class II | 2021-04-08 |
| K202134 | Well Lead All Silicone Foley Catheter with Temperature Sensor | Well Lead Medical Co., Ltd. | EZL | Class II | 2021-04-08 |
| K203767 | Pristine Long-Term Hemodialysis Catheter | C B Bard, Inc. | MSD | Class II | 2021-04-02 |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | Pentax of America, Inc. | FDT | Class II | 2021-04-01 |
| K210631 | Avitus(r) Bone Harvester | Avitus Orthopaedics, Inc. | KNW | Class II | 2021-03-31 |
| K210654 | EnCor Breast Biopsy Probe with Rinse Tube | Senorx, Inc. | KNW | Class II | 2021-03-31 |
| K201001 | Modulith SLX-F2 | Karl Storz Endoscopy America | LNS | Class II | 2021-03-30 |
| K203133 | ENvizion Medical ENvue ENvizion Medical Enteral Feeding Tube | Envizion Medical , Ltd. | KNT | Class II | 2021-03-24 |
| K192731 | ZIDA Wearable Neuromodulation System | Exodus Innovations | NAM | Class II | 2021-03-19 |
| K210584 | SDC3 HD Information Management System with Wireless Device Control Capability | Stryker | GCJ | Class II | 2021-03-18 |
| K202438 | Ensure Single-Use Coagulation Forceps | Micro-Tech (Nanjing) Co., Ltd. | KGE | Class II | 2021-03-15 |
| K201866 | NovaLine Tubing Sets for Hemodialysis | Bain Medical Equipment (Guangzhou) Co., Ltd. | FJK | Class II | 2021-03-10 |
| K201809 | AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber Accessory | Baxter Healthcare Corportation | KDI | Class II | 2021-03-10 |
| K202838 | Andorate Universal Endoscope Tip Guard | Ga Health Company Limited | OCU | Class II | 2021-03-05 |
| K202166 | Senhance Surgical System | Transenterix, Inc. | NAY | Class II | 2021-03-02 |
| K210266 | OverStitch Sx Endoscopic Suturing System | Apollo Endosurgery, Inc. | OCW | Class II | 2021-03-02 |
| K201436 | Vortek Single Loop Ureteral Stent | Coloplast Corp. | FAD | Class II | 2021-02-25 |
| K203255 | 4K UHD Laparoscope | Scivita Medical Technology Co., Ltd. | GCJ | Class II | 2021-02-24 |
| K202616 | ClearCap Distal Attachment | Finemedix Co., Ltd. | OCX | Class II | 2021-02-19 |
| K202303 | CORE E3 Suction/irrigator | Conmed Corporation | GCJ | Class II | 2021-02-19 |
| K203632 | da Vinci S/Si (IS2000/IS3000) 5mm and 8mm Reusable Instruments, da Vinci Xi/X (IS4000/IS4200) 8mm Reusable Instruments | Intuitive Surgical, Inc. | NAY | Class II | 2021-02-10 |
| K201121 | Sphincterotome | Hangzhou AGS MedTech Co., Ltd. | KNS | Class II | 2021-02-05 |
| K203603 | Monopolar Hook | Human Xtensions , Ltd. | GCJ | Class II | 2021-02-01 |
| K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Steris | NZA | Class II | 2021-01-28 |
| K201650 | VMCore Biopsy Needle | Uro-1, Inc. | KNW | Class II | 2021-01-15 |
| K201897 | Sensor-Ureterorenoscope 9 FR WL 600 MM (short RIWO D-URS), Adapter For Controller 5525 | Richard Wolf Medical Instruments Corporation | FGB | Class II | 2021-01-15 |
| K202333 | Lockado Repositionable Hemostasis Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2021-01-14 |
| K202104 | BioGuard EUS Air/Water and Suction Valves | STERIS Corporation | ODC | Class II | 2021-01-14 |
| K201014 | MyOnyx System | Thought Technology , Ltd. | KPI | Class II | 2021-01-13 |
| K203397 | Marrow-Pack (white)- 11gauge/10cm or 13gauge/10cm, Marrow-Tray (red)- 11gauge/10cm or 13gauge/10cm, Marrow-Set (violet)- 11gauge/10cm or 13gauge/10cm, Marrow-kit (grey)- 11gauge/10cm or 13gauge/10cm, Marrow-Stem (green)- 11gauge/10cm or 13gauge/10cm | Biopsybell S.R.L. | KNW | Class II | 2021-01-11 |
| K203630 | BioGuard Air/Water and Suction Valves | Steris Corporations | ODC | Class II | 2021-01-08 |
| K200021 | Applied Medical Anoscope | Applied Medical Resources | FER | Class II | 2021-01-06 |
| K200769 | Disposable Endoscope Valves Set, Disposable Endoscope Valves Set B | Wilson Instruments (Sha) Co., Ltd. | ODC | Class II | 2021-01-06 |
| K201776 | Foley Balloon Catheter for Urology | Apollon Co., Ltd. | EZL | Class II | 2020-12-30 |
| K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | Pentax of America, Inc. | ODG | Class II | 2020-12-30 |
| K202940 | First Relief v1 | Dyansys, Inc. | QHH | Class II | 2020-12-29 |
| K203062 | Optiflux Series of Dialyzers F160NR, F180NR, F200NR | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2020-12-28 |
| K200426 | Acute Dual Lumen Hemodialysis Catheter | Health Line International Corporation | MPB | Class II | 2020-12-24 |
| DEN200016 | EndoRotor Device | Interscope, Inc. | QNE | Class II | 2020-12-23 |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood Tube Set | Quanta Dialysis Technologies, Ltd. | KDI | Class II | 2020-12-23 |
| K202237 | Locking device | Hangzhou AGS MedTech Co., Ltd. | ODC | Class II | 2020-12-23 |
| K200473 | SoloAsisst II, Voice Control | Aktormed GmbH | NAY | Class II | 2020-12-22 |
| K202968 | Da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2020-12-22 |
| K203162 | Advanix Biliary Stent with NaviFlex RX Delivery System | Boston Scientific Corporation | FGE | Class II | 2020-12-18 |
| K202925 | KARL STORZ ICG Imaging System | Karl Storz Endoscopy_America, Inc. | OWN | Class II | 2020-12-17 |
| K201509 | Disposable Stone Extraction basket | Hangzhou AGS MedTech Co., Ltd. | LQR | Class II | 2020-12-16 |
| K201808 | X-Tack Endoscopic HeliX Tacking System | Apollo Endosurgery, Inc. | PKL | Class II | 2020-12-15 |
| K202698 | Prefilled Syringe | Hangzhou Primecare Medical Co., Ltd. | EZL | Class II | 2020-12-15 |
| K202834 | da Vinci Xi Surgical System (IS4000), da Vinci X Surgical System (IS4200) | Intuitive Surgical, Inc. | NAY | Class II | 2020-12-10 |
| K202560 | AquaPulse Irrigation Tubing | Ga Health Company Limited | OCX | Class II | 2020-12-10 |
| K203119 | ClearPetra Suction-Evacuation Sheath | Well Lead Medical Co., Ltd. | FED | Class II | 2020-12-09 |
| K202661 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | FDT | Class II | 2020-12-08 |
| K200646 | TubeClear System | Actuated Medical, Inc. | KNT | Class II | 2020-12-04 |
| K200404 | ORISE ProKnife | Boston Scientific Corporation | KNS | Class II | 2020-12-03 |
| K203199 | RAS 12 Rack / RAS 12 Long Rack, used in RAS Cycle of AMSCO 7052HP / 7053HP Single Chamber Washer-Disinfector | STERIS Corporation | NVE | Class II | 2020-12-01 |
| DEN200029 | Parallel | Mahana Therapeutics, Inc. | QMY | Class II | 2020-11-25 |
| K193155 | Nipro Dry Complete Dry Acid Concentrate for Hemodialysis | Nipro Renal Solutions USA, Corp. | KPO | Class II | 2020-11-25 |
| K201815 | Dornier MAGELLAN Ureteral Access Sheath | Dornier Medtech America, Inc. | FED | Class II | 2020-11-20 |
| K201526 | TIPCAM1 Rubina Video Endoscope System | Karl Storz Endoscopy America | GCJ | Class II | 2020-11-20 |
| K201867 | Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System | Baxter Healthcare Corporation | FKX | Class II | 2020-11-19 |
| K202150 | GlidePath 7.5F Long-Term Dialysis Catheter | C.R. Bard, Inc. | MSD | Class II | 2020-11-18 |
| K202931 | Disposable Trocar | Wuxi Shukang Medical Appliance Co., Ltd. | GCJ | Class II | 2020-11-17 |
| K200820 | SpeediCath Compact Set | Coloplast | GBM | Class II | 2020-11-13 |
| K202571 | da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories | Intuitive Surgical, Inc. | NAY | Class II | 2020-11-12 |
| K202583 | BioShield biopsy valve EUS - Linear | STERIS Corporation | ODD | Class II | 2020-11-06 |
| K201741 | Gabriel 3 Way EnFit Valve | Syncro Medical Innovations, Inc. | PIF | Class II | 2020-11-05 |
| K202244 | SPY-PHI System with SPY-PHI Fluorescence Assessment Software | Novadaq Technologies Ulc. (Now A Part of Stryker) | OWN | Class II | 2020-11-05 |
| K200071 | Blue Beacon Submucosal Injectable Solution | Micro-Tech (Nanjing) Co., Ltd. | PLL | Class II | 2020-11-03 |
| K192904 | SpeediCath Compact Set | Coloplast | GBM | Class II | 2020-11-02 |
| K203028 | FUJIFILM Distal End Cap | Fujifilm Corporation | FDT | Class II | 2020-10-30 |
| K202646 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | FET | Class II | 2020-10-29 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.