Review Panel
Gastroenterology, Urology FDA 510(k) Clearances & Devices
- Cleared Devices
- 11,341
- Product Codes (page)
- 53
- Latest Decision
- 2020-10-29
Clearances · page 14 of 114
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K202539 | Nutriglide(TM) Nasal Feeding Tube | Applied Medical Technology, Inc. | KNT | Class II | 2020-10-29 |
| K202957 | Flexible Video Cysto-Urethroscope (C-view) | KARL STORZ Endoscopy-America, Inc. | FAJ | Class II | 2020-10-29 |
| K193169 | Nelson Sentinel Series Basic Chlorine Sentinel | Nelson Environmental Technologies, Inc. | MSY | Class II | 2020-10-29 |
| K202469 | G-EYE System | Smart Medical Systems , Ltd. | FDF | Class II | 2020-10-26 |
| K201155 | PleurX Peritoneal Catheter System | Care Fusion | PNG | Class II | 2020-10-21 |
| K201771 | Single Use Rotatable and Repositionable Hemoclip | Anrei Medical (Hangzhou) Co., Ltd. | PKL | Class II | 2020-10-19 |
| K200757 | Foley Catheter with Temperature Sensor | Deroyal Industries, Inc. | EYC | Class II | 2020-10-15 |
| K202285 | Medline ENfit OTC Feeding Syringe | Medline Industries, Inc. | PNR | Class II | 2020-10-09 |
| K200103 | BIOTEQ Drainage Catheter Set (One Step Type) | Bioteque Corporation | FGE | Class II | 2020-10-09 |
| K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) | Stryker | GCJ | Class II | 2020-10-08 |
| K202478 | Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares | Boston Scientific Corporation | FDI | Class II | 2020-10-08 |
| K193542 | Clearum HS Family, Clearum HS Models: HS 13, HS 15, HS 17, HS 20, HS 22 | Bellco Srl | KDI | Class II | 2020-10-08 |
| K200217 | ClearEndoclip | Finemedix Co., Ltd. | PKL | Class II | 2020-10-05 |
| K202357 | Nutricare Clear-ISOSAF Nasogastric Feeding Tube | Three Circles Consulting Limited | PIF | Class II | 2020-10-01 |
| K202376 | EverLift Submucosal Lifting Agent | Gi Supply, Inc. | PLL | Class II | 2020-09-30 |
| K202566 | Wiygul Catheter | Big Blue Biotech, Inc. | EZD | Class II | 2020-09-30 |
| K200557 | Enteral Feeding Syringes with ENfit connector (Model: 10 ml; 60 ml control ring) | Jiangsu Shenli Medical Production Co., Ltd. | PNR | Class II | 2020-09-28 |
| K192717 | da Vinci SP Surgical System | Intuitive Surgical, Inc. | NAY | Class II | 2020-09-28 |
| K202477 | EndoGI S-Path Biliary Stent System | Endo GI Medical | FGE | Class II | 2020-09-24 |
| K192707 | Optiflux F180NR Dialyzer | Fresenius Medical Care Renal Therapies Group, LLC | KDI | Class II | 2020-09-21 |
| K202287 | Ran-Flex-B Bone Marrow Aspiration Needle | Ranfac Corporation | KNW | Class II | 2020-09-18 |
| K201207 | CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin Line | Fresenius Medical Care Renal Therapies Group, LLC | KOC | Class II | 2020-09-18 |
| K202286 | Tulsa-Pro System | Profound Medical, Inc. | PLP | Class II | 2020-09-16 |
| K193657 | Disposable Enteral Feeding Syringe with Enfit Connector | Shinva Ande Healthcare Apparatus Co., Ltd. | PNR | Class II | 2020-09-12 |
| K201134 | Arthrex NanoScope System | Arthrex, Inc. | GCJ | Class II | 2020-09-04 |
| K202176 | Symetrex LTHD Catheter, Symetrex LTHD Catheter with Sideholes | Medical Components, Inc. (dba MedComp) | MSD | Class II | 2020-09-03 |
| K201074 | Delta III Lithotripter | Dornier Medtech America, Inc. | LNS | Class II | 2020-09-03 |
| K192704 | Endofresh Digestive Endoscopy System | Huizhou Xzing Technology Co., Ltd. | FDS | Class II | 2020-09-02 |
| K201765 | SmartHDM-510 System | Mesa Laboratories, Inc. | FIZ | Class II | 2020-09-02 |
| K201135 | Image1 S CCU, Image1 S 4U Camera Head | KARL STORZ Endoscopy-America, Inc. | FET | Class II | 2020-09-01 |
| K201920 | Endoscope Reprocessor OER-Elite | Olympus Medical Systems Corp. | FEB | Class II | 2020-09-01 |
| K193424 | Resolution 360 ULTRA Clip | Boston Scientific Corporation | PKL | Class II | 2020-09-01 |
| DEN190042 | Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 Dialyzer | Baxter Healthcare Corporation | QAX | Class II | 2020-08-28 |
| K201166 | Temno Elite Biopsy System | Merit Medical Systems, Inc. | KNW | Class II | 2020-08-28 |
| K200369 | OES Elite Ureteroscopes and Accessories | Olympus Winter & Ibe GmbH | FGB | Class II | 2020-08-28 |
| K193005 | DIMI RRT System | Dialco Medical, Inc. | KDI | Class II | 2020-08-28 |
| K190864 | Konix Anti-Fog Solution | Turkuaz Saglik Hizmetleri Medikal Temizlik Kimyasal Urunler | OCT | Class II | 2020-08-27 |
| K201805 | VersaOne Reusable Positioning Trocar System | Covidien | GCJ | Class II | 2020-08-26 |
| K202130 | FUJIFILM Video Laparoscope | Fujifilm Corporation | GCJ | Class II | 2020-08-20 |
| K202012 | Mammotome Revolve Dual Vacuum Assisted Biopsy (VAB) System | Devicor Medical Products, Inc. | KNW | Class II | 2020-08-18 |
| K201399 | HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head | Karl Storz-Endoscopy-America, Inc. | OWN | Class II | 2020-08-17 |
| K201244 | Concorde Models Concorde US and Concorde ST Soft Tissue Biopsy Devices | Transmed7, LLC | KNW | Class II | 2020-08-07 |
| K201641 | Disposable Laparoscope Trocar | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | GCJ | Class II | 2020-08-06 |
| K192991 | Vesco Medical Extension Feeding Set | Vesco Medical, LLC | PIF | Class II | 2020-08-03 |
| K201837 | UroLift 2 System (formerly UL500), UroLift 2 Delivery Handle, UroLift 2 Implant Cartridge | Neotract, Inc. | PEW | Class II | 2020-07-31 |
| K192499 | Cyber Blade | SIDAM S.r.l. | GCJ | Class II | 2020-07-31 |
| K201511 | Reprocessed Endoscopic Trocars and Sleeves | Stryker Sustainability Solutions | NLM | Class II | 2020-07-31 |
| K200142 | SpeediCath Soft | Coloplast | GBM | Class II | 2020-07-30 |
| K200082 | BD Univia RightFit Enteral Extension Sets and Transitional Adapters | Mps Medical, Inc. | PIF | Class II | 2020-07-30 |
| K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | Stryker | GCJ | Class II | 2020-07-28 |
| K201293 | Ureterorenoscope System | Shanghai AnQing Medical Instrument Co., Ltd. | FGB | Class II | 2020-07-24 |
| K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type) | Pentax of America, Inc. | ODG | Class II | 2020-07-23 |
| K201200 | Visera Elite II Video System Center | Olympus Medical Systems Corp. | FET | Class II | 2020-07-22 |
| K200542 | Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head | Olympus Medical Systems Corp. | OWN | Class II | 2020-07-17 |
| K192793 | Evis Exera III Colonovideoscope Olympus PCF-H190TL, Evis Exera III Colonovideoscope Olympus PCF-H190TI, Evis Exera III Colonovideoscope Olympus PCF-HQ190L, Evis Exera III Colonovideoscope Olympus PCF-HQ190I | Olympus Medical Systems Corp. | FDF | Class II | 2020-07-17 |
| K201098 | Ambu Duodeno System | Ambu Innovation GmbH | FDT | Class II | 2020-07-17 |
| K201198 | S+N Laparoscopes, 4KO, Autoclavable, S+N Bariactric Laparoscopes, 4KO, Autoclavable | Smith & Nephew | GCJ | Class II | 2020-07-17 |
| K201243 | Disposable Specimen Retrieval Bag | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | GCJ | Class II | 2020-07-10 |
| K193272 | GTK Trocars | Guangzhou T.K Medical Instrument Co., Ltd. | GCJ | Class II | 2020-07-09 |
| K201035 | ETHICON Linx Esophagus Sizing Tool | Torax Medical, Inc. | QJN | Class II | 2020-07-09 |
| K192928 | Optiflux Enexa F500 Dialyzer | Fresenius Medical Care Reanal Therapies Group, LLC | KDI | Class II | 2020-07-09 |
| K201593 | Looking Glass 4K Integrated Visualization System | Conmed Corporation | GCJ | Class II | 2020-07-08 |
| K200850 | Fujifilm Ultrasonic Processor | Fujifilm Corporation | FDS | Class II | 2020-07-06 |
| K201048 | SherpaPak Pediatric Liver Transport System | Paragonix Technologies | KDN | Class II | 2020-07-02 |
| K193600 | EndoGI Biliary Stent System | Endogi Medical, Ltd. | FGE | Class II | 2020-06-26 |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | Ga Health Company Limited | ODC | Class II | 2020-06-24 |
| K200617 | Logic HD Camera Controller, Logic HD Lite Camera Controller, Logic 4K Camera Contoller, Adapter for Controller 5525 | Richard Wolf Medical Instruments Corporation | FET | Class II | 2020-06-23 |
| K201096 | CO2mbiLED | Karl Storz Endoscopy America, Inc. | FCX | Class II | 2020-06-23 |
| K201151 | O-Mec 690 Series Laparoscopes | Omec Medical, Inc. | GCJ | Class II | 2020-06-22 |
| K200627 | GlidePath 10F Long-Term Dialysis Catheter | C.R. Bard, Inc. | MSD | Class II | 2020-06-22 |
| K191923 | EverLift Submucosal Lifting Agent | Gi Supply | PLL | Class II | 2020-06-20 |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | Ga Health Company Limited | ODC | Class II | 2020-06-18 |
| K201322 | Entuit Nasal Jejunal Feeding Tube | Wilson-Cook Medical, Inc. | KNT | Class II | 2020-06-17 |
| K201007 | In-Ka Ureteral Balloon Dilatation Catheter | Coloplast Corp. | EZN | Class II | 2020-06-11 |
| K200441 | UroLift Advanced Tissue Control (ATC) System | Neotract, Inc. | PEW | Class II | 2020-06-05 |
| K200684 | gastroduodenal FTRD Set | Ovesco Endoscopy AG | PKL | Class II | 2020-06-02 |
| K200134 | Jimushi Sterile Urethral Catheter for single use | Hangzhou Jimushi Meditech Co., Ltd. | GBM | Class II | 2020-06-01 |
| DEN190037 | NaviCam Capsule Endoscope System with NaviCam Stomach Capsule | Anx Robotica, Inc. | QKZ | Class II | 2020-05-22 |
| K200419 | Kalera Vacuum Aspiration Catheter (K-VAC) | Kalera Medical, Inc. | FED | Class II | 2020-05-22 |
| K191512 | LotusCatheter (Lotus No Balloon Catheter) | Hakki Medical Technologies, Inc. | GBM | Class II | 2020-05-21 |
| K200483 | SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller | Boston Scientific Corporation | FBN | Class II | 2020-05-21 |
| K201106 | IntraMarX 3D Radiopaque Marker | Anx Robotica Corp | FFX | Class II | 2020-05-21 |
| K192342 | Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories) | Hangzhou AGS MedTech Co., Ltd. | KNS | Class II | 2020-05-21 |
| K200737 | SPY Portable Handheld Imaging (SPY-PHI) System | Novadaq Technologies Ulc. (Now A Part of Stryker) | OWN | Class II | 2020-05-21 |
| K200479 | AquaPulse Auxiliary Water Connector | Ga Health Company Limited | OCX | Class II | 2020-05-15 |
| K192048 | Single Use Endoscope Valves Set | Anrei Medical (Hangzhou) Co., Ltd. | ODC | Class II | 2020-05-14 |
| K200989 | Reliance Endoscope Processing System | STERIS Corporation | NZA | Class II | 2020-05-14 |
| K192209 | Citrasate Dry Acid Concentrate, Granuflo Dry Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2020-05-08 |
| K192577 | Actreen Hi-Lite Intermittent Urinary Catheters | B.Braun Medical, Inc. | GBM | Class II | 2020-05-07 |
| K200293 | InMode System with vTone Applicator | InMode , Ltd. | KPI | Class II | 2020-05-05 |
| K192286 | FUJIFILM EP-6000 Video Processor | Fujifilm Corporation | FET | Class II | 2020-05-01 |
| K200173 | Stone Retrieval Balloon | Hangzhou AGS MedTech Co., Ltd. | GCA | Class II | 2020-05-01 |
| K200902 | ClickClean | Medeon Biodesign, Inc. | GCJ | Class II | 2020-04-30 |
| K191866 | GelPOINT Mini Advanced Access Platform | Applied Medical | GCJ | Class II | 2020-04-29 |
| K192803 | da Vinci Xi Surgical System, da Vinci X Surgical System | Intuitive Surgical | NAY | Class II | 2020-04-29 |
| DEN180055 | CARPEDIEM System | Bellco Srl (Now Part of Medtronic, Inc) | QIR | Class II | 2020-04-29 |
| K192498 | Single Use Injector | Olympus Medical Systems Corp. | FBK | Class II | 2020-04-28 |
| K192017 | Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate | Fresenius Medical Care Renal Therapies Group, LLC | KPO | Class II | 2020-04-24 |
| K192408 | Custodiol HTK Solution | Dr. Franz Kohler Chemie GmbH | KDL | Class II | 2020-04-24 |
| K192807 | Duo-Flow Side x Side Double Lumen Catheter | Medical Components, Inc. (dba MedComp) | MPB | Class II | 2020-04-23 |
11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.