Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 46
- Latest Decision
- 2022-07-12
Clearances · page 11 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K213143 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2022-07-12 |
| K221293 | E-Brik Visualization Assistant | Jdi Surgical, Inc. | OCT | Class II | 2022-07-07 |
| K212819 | Disposable Biopsy Refill Needle | Suzhou Leapmed Healthcare Corporation | FCG | Class II | 2022-07-06 |
| K212820 | Disposable Semi Automatic Biopsy Instrument | Suzhou Leapmed Healthcare Corporation | KNW | Class II | 2022-07-06 |
| K212822 | Disposable Coaxial Biopsy Needle | Suzhou Leapmed Healthcare Corporation | FCG | Class II | 2022-07-06 |
| K213232 | NovaCore Semi-Automatic Biopsy Instrument | Argon Medical Devices | KNW | Class II | 2022-07-01 |
| K221625 | 2-Way 100% Silicone ClearTract Catheter | Silq Technologies Corporation | EZL | Class II | 2022-07-01 |
| K221611 | 780 nm L11 LED Light Source with AIM | Stryker | OWN | Class II | 2022-06-29 |
| K213818 | VersaOne Optical Trocar with Fixation Balloon Cannula, VersaOne Universal Fixation Balloon Cannula | Covidien | GCJ | Class II | 2022-06-27 |
| K220790 | Disposable Polypectomy Snare, Disposable Polypectomy Hybrid Snare | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | FDI | Class II | 2022-06-27 |
| K213338 | CORE-CLIP | Incore Co., Ltd. | PKL | Class II | 2022-06-23 |
| K213283 | GentleCath Air for Men Hydrophilic Intermittent Urinary Catheter | Convatec Limited | GBM | Class II | 2022-06-22 |
| K211148 | CORE-Trocar | Incore Co., Ltd. | GCJ | Class II | 2022-06-21 |
| K221217 | SPY Laparoscope | Stryker | GCJ | Class II | 2022-06-17 |
| K220210 | Disposable Endoscopy Adapter Set | Yangzhou Fartley Medical Instrument Technology Co., Ltd. | ODC | Class II | 2022-06-17 |
| K221387 | BEL-GEN Cold Storage Solution | Institut Georges Lopez | KDL | Class II | 2022-06-14 |
| K212808 | Logic Hd camera head green, System green | Richard Wolf Medical Instruments Corporation | FET | Class II | 2022-06-14 |
| K221386 | PERF-GEN Pulsatile Perfusion Solution | Institut Georges Lopez | KDL | Class II | 2022-06-14 |
| DEN220006 | ProdiGI | Covidien, LLC | QSW | Class II | 2022-06-13 |
| K220157 | Disposable Hemostatic Closure Clip Device | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2022-06-13 |
| K213258 | Nasogastric Feeding Tubes - ENFit Port - PVC | Cair Lgl | PIF | Class II | 2022-06-09 |
| K221071 | Niti-S Biliary Slim M Stent | Taewoong Medical Co., Ltd. | FGE | Class II | 2022-06-09 |
| K211909 | Cysto-Gastro-Sets | G-Flex Europe Sprl | KNS | Class II | 2022-06-09 |
| K213185 | ImaJin Silicone double loop ureteral stent kits, ImaJin Pyelostent Silicone double loop ureteral stent kits, ImaJin Stenostent Silicone double loop ureteral stent kits | Coloplast Corp. | FAD | Class II | 2022-06-08 |
| K220455 | Lap-Band System Calibration Tube | Reshape Lifesciences | KNT | Class II | 2022-06-07 |
| K213222 | Disposable Polypectomy Snare | Beijing Zksk Technology Co., Ltd. | FDI | Class II | 2022-06-06 |
| K213223 | Multi-Band Ligator | Beijing Zksk Technology Co., Ltd. | FHN | Class II | 2022-06-06 |
| K214063 | Model 121 Biopsy Needle, Model 111 Biopsy Needle, Model 112 Biopsy Needle, and Model 131 Disposable Coaxial Biopsy Needle | Guangzhou Shengwei Medical Devices Co., Ltd. | KNW | Class II | 2022-06-03 |
| K214089 | FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M2 | Fujifilm Corporation | ODG | Class II | 2022-06-03 |
| K213924 | Gastric Alimetry System | Alimetry , Ltd. | MYE | Class II | 2022-06-03 |
| K213239 | Endoscopic Injection Needle | Beijing Zksk Technology Co., Ltd. | FBK | Class II | 2022-06-02 |
| K221264 | FROG Forceps Valve (VAL1-F1-100) | Fujifilm Medwork GmbH | ODC | Class II | 2022-06-01 |
| K212669 | Single Use Hemoclip | Zhejiang Chuangxiang Medical Technology Co., Ltd. | PKL | Class II | 2022-05-27 |
| K220889 | Senhance Surgical System | Asensus Surgical, Inc. | NAY | Class II | 2022-05-27 |
| K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | Stryker | GCJ | Class II | 2022-05-25 |
| K220065 | Single Use Ureteral Access Sheath | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FED | Class II | 2022-05-25 |
| K213174 | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection | Cardinalhealth | PIF | Class II | 2022-05-19 |
| K220218 | Siren SGT | Tools For Surgery, LLC | KNT | Class II | 2022-05-18 |
| K210575 | HDF Assist Mudule, HDF Infusion Set and Substitution Filter | Nephros | KDI | Class II | 2022-05-13 |
| K221174 | Telepack + | Karl Storz Endoscopy America, Inc. | FET | Class II | 2022-05-13 |
| K212620 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2022-05-12 |
| K220587 | Evis Exera III Duodenovideoscope Olympus TJF-Q190V | Olympus Medical Systems Corp. | FDT | Class II | 2022-05-11 |
| K213946 | Compass BDS Biliary Stent | Cook Ireland, Ltd. | FGE | Class II | 2022-05-09 |
| K211021 | Sterile Biliary Stone Retrieval Balloon Catheter, Retrieval Balloon / short-wire compatible | Micro-Tech (Nanjing) Co., Ltd. | FGE | Class II | 2022-05-06 |
| K212582 | SpyGlass Discover Balloon Dilation Catheter | Boston Scientific Corporation | GCA | Class II | 2022-05-06 |
| K212430 | BONREE Nelaton Catheter | Bonree Medical Co., Ltd. | EZD | Class II | 2022-04-29 |
| K213334 | Monarch Platform, Urology | Auris Health, Inc. | FGB | Class II | 2022-04-29 |
| K210250 | SpeedCath Compact Male | Coloplast | EZD | Class II | 2022-04-26 |
| K213483 | SnapLoc Wire Lock | Wilson Cook Medical | ODC | Class II | 2022-04-26 |
| K220588 | Avanos* CORTRAK* 2 Enteral Access System (EAS) | Avanos Medical, Inc. | KNT | Class II | 2022-04-22 |
| K213683 | Promisemed Fine Biopsy Needle | Promisemed Hangzhou Meditech Co., Ltd. | KNW | Class II | 2022-04-22 |
| K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) | Stryker | GCJ | Class II | 2022-04-22 |
| K220872 | Saberscope5 Laparoscope | Xenocor, Inc. | GCJ | Class II | 2022-04-20 |
| K212522 | Lilliput APD System | Fresenius Medical Care Renal Therapies Group, LLC | FKX | Class II | 2022-04-15 |
| K210419 | BIOTEQ Drainage Catheter BT-PDS-series | Bioteque Corporation | FGE | Class II | 2022-04-13 |
| K213133 | Keffort (MC-100, MC-100A) | Oriental Inspiration Limited | KPI | Class II | 2022-04-13 |
| K212202 | WiScope Digital Cystoscope System, WiScope Single-Use Digital Flexible Cystoscope, WiScope Image System | OTU Medical, Inc. | FAJ | Class II | 2022-04-13 |
| K220477 | Cellvizio 100 series system with confocal Miniprobes | Mauna Kea Technologies | OWN | Class II | 2022-04-11 |
| K220158 | G-EYE System | Smart Medical Systems , Ltd. | FDF | Class II | 2022-04-11 |
| K213015 | DORA Disposable A.V. Fistula Needle Sets | Bain Medical Equipment (Guangzhou) Co., Ltd. | FIE | Class II | 2022-04-08 |
| K213578 | Balloon Dilatation Catheter | Hangzhou AGS MedTech Co., Ltd. | FDF | Class II | 2022-04-06 |
| K211882 | HD-550 Video Endoscope System | Sonoscape Medical Corp. | NWB | Class II | 2022-04-01 |
| K212216 | Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 set | Baxter Healthcare Corporation | KDI | Class II | 2022-04-01 |
| K210052 | Saneso Colonoscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Colonoscope-A (Model: with/without Select Band Imaging (SBI)), Saneso Gastroscope 360-A (Model: with/without Select Band Imaging (SBI) and with/without Dual Band Imaging(DBI)), Saneso Single Camera Gastroscope-A (Model: with/without Select Band Imaging (SBI)) | Saneso, Inc. | FDF | Class II | 2022-04-01 |
| K211043 | Alexis Contained Extraction System | Applied Medical Resources Corporation | GCJ | Class II | 2022-03-31 |
| K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | KNW | Class II | 2022-03-30 |
| K220247 | Guidewire Locking Device | Micro-Tech (Nanjing) Co., Ltd. | ODC | Class II | 2022-03-29 |
| K213860 | ArthroFree Wireless Surgical Camera System | Lazurite Holdings, LLC | GCJ | Class II | 2022-03-23 |
| K212999 | Multi-Functional Electrosurgical Knife | Anrei Medical (Hangzhou) Co., Ltd. | KNS | Class II | 2022-03-21 |
| K214016 | 15L Cycler Drainage Bag | Baxter Healthcare Corporation | KDJ | Class II | 2022-03-18 |
| K213444 | RELIEF Ureteral Stent Kit; Model: RS-001 - 6 Fr x 24cm, RELIEF Ureteral Stent Kit; Model: RS-002 - 6 Fr x 26cm | Ureteral Stent Company | FAD | Class II | 2022-03-17 |
| K220395 | EndoGator Endoscopy Irrigation Tubing | STERIS Corporation | FEQ | Class II | 2022-03-11 |
| K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | STERIS Corporation | NZA | Class II | 2022-03-10 |
| K220069 | 4K UHD LCD Monitor OEV321UH | Olympus Medical Systems Corp. | GCJ | Class II | 2022-03-09 |
| K203637 | SpeediCath Compact (28578, 28580, 28582, 28584), SpeediCath Compact Plus (28810, 28812, 28814) | Coloplast | EZD | Class II | 2022-03-08 |
| K211787 | Hemoclip | Hangzhou AGS MedTech Co., Ltd. | PKL | Class II | 2022-03-03 |
| K213135 | Plasma Edge resection and vaporization electrodes, Plasma Edge working elements, Adaptor Plasma Edge | Chirurgie Innovation | FAS | Class II | 2022-03-02 |
| K201861 | Bio Fluff System | Gnali Bocia S.R.L. | KPL | Class II | 2022-03-02 |
| K211661 | ENFit enteral syringes (NUTRIFIT) | Pentaferte Italia S.R.L. | PNR | Class II | 2022-02-28 |
| K212668 | Sclerotherapy Needle | Zhejiang Chuangxiang Medical Technology Co., Ltd. | FBK | Class II | 2022-02-23 |
| K211686 | Flexible Video-Choledo-Cysto-Ureteroscope System | Shanghai SeeGen Photoelectric Technology Co., Ltd. | FGB | Class II | 2022-02-22 |
| K211212 | LoFric Elle | Dentsply Sirona | EZD | Class II | 2022-02-17 |
| K213710 | da Vinci Fluorescence Imaging Vision System, da Vinci Firefly Imaging System | Intuitive Surgical, Inc. | NAY | Class II | 2022-02-17 |
| K213186 | NovoFlow Reinforced Ureteral Stent | Coloplast Corp. | FAD | Class II | 2022-02-16 |
| K213606 | EvoEndo Single-Use Endoscopy System | EvoEndo, Inc. | FDS | Class II | 2022-02-14 |
| K220007 | Pure-Vu EVS System | Motus GI Medical Technologies , Ltd. | FDF | Class II | 2022-02-10 |
| K220108 | SDC4K Information Management System with Device and Voice Control Package | Stryker Endoscopy | GCJ | Class II | 2022-02-09 |
| K212658 | CloudCath Peritoneal Dialysis Drain Set Monitoring System | Cloudcath | FKX | Class II | 2022-02-09 |
| K220053 | Diathermic Slitter (FlushKnife) DK2620JI and DK2623JI | Fujifilm Corporation | KGE | Class II | 2022-02-04 |
| K212382 | Ambu® aScope Gastro, Ambu® aBox2 | Ambu A/S | FDS | Class II | 2022-02-03 |
| K212079 | TeesuVac Breast Biopsy Device Mark 1 | Teesuvac Aps | KNW | Class II | 2022-02-02 |
| K220023 | 8mm Monopolar Curved Scissors | Intuitive Surgical, Inc. | NAY | Class II | 2022-01-31 |
| K211436 | Intermittent Catheter (Not Finalized) | Hollister Incorporated | GBM | Class II | 2022-01-27 |
| K212868 | JFil Ureteral Stents, JFil Ureteral Stents ECO KIT | Rocamed Sam | FAD | Class II | 2022-01-26 |
| K213639 | Revaclear 500, Revaclear 400, Revaclear 300 | Baxter Healthcare Corporation | KDI | Class II | 2022-01-24 |
| K213356 | Entuit PEG, Entuit PEGJ | Wilson-Cook Medical, Inc. | PIF | Class II | 2022-01-20 |
| K212748 | Disposable Dual Action Tissue Clip | Micro-Tech (Nanjing) Co., Ltd. | PKL | Class II | 2022-01-20 |
| K212458 | Flexible Video-Uretero-Renoscope SSU System | Karl Storz Endoscopy America | FGB | Class II | 2022-01-20 |
| K211333 | KIDNEY ASSIST-transport | Xvivo Perfusion AB | KDN | Class II | 2022-01-20 |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing Aid | Medivators, Inc. | FEB | Class II | 2022-01-14 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.