meddevicedb.com FDA Device Reference

Review Panel

Gastroenterology, Urology FDA 510(k) Clearances & Devices

Cleared Devices
11,341
Product Codes (page)
52
Latest Decision
2020-04-23

Clearances · page 15 of 114

K-Number Trade Name Applicant / Manufacturer Product Code Class Decision Date
K192183 RocaTub Ureteral Catheter Promepal Sam EYB Class II 2020-04-23
K200053 DANNIK Specimen Retrieval System with deployment mechanism, DANNIK Specimen Retrieval System (Bag Only) Dannik GCJ Class II 2020-04-21
K200745 Lariat, Hot/Cold Snare United States Endoscopy Group, Inc. FDI Class II 2020-04-21
K192034 HDX 100% Silicone 2-way Foley Catheter, 14Fr/10cc, HDX 100% Silicone 2-way Foley Catheter, 16Fr/5cc, HDX 100% Silicone 2-way Foley Catheter, 18Fr/10cc Pathway, LLC EZL Class II 2020-04-21
K193161 Pristine Scope Pristine Surgical GCJ Class II 2020-04-21
K200670 EON Portable RO Water Purification System Mar Cor Purification, Inc. FIP Class II 2020-04-16
K192588 G-EYE System Smart Medical Systems , Ltd. FDF Class II 2020-04-15
K191930 7 mm Extended Length Endoscope Maquet Cardiovascular, LLC GCJ Class II 2020-04-15
K200388 Vacutore Air/Water Bottle Tubing, Vacutore CO2 Tubing with Luer Connector Ga Health Company Limited OCX Class II 2020-04-14
K200517 Standard Trocar Standard Bariatrics GCJ Class II 2020-04-09
K191885 Standard Bougie Standard Bariatrics KNT Class II 2020-04-08
K193250 Irrigation Tubing with CO2 or Air Keymed (Medical and Industrial Equipment) , Ltd. OCX Class II 2020-04-06
K200577 RAS 12 Rack, RAS 12 Long Rack, RAS Cycle of the AMSCO 7052HP/7053HP Single Chamber Washer/Disinfector STERIS Corporation NVE Class II 2020-04-03
K193026 Visera Elite II Video System Center, Visera Elite II Endoeye 3D Olympus Medical Systems Corp. GCJ Class II 2020-04-03
K192101 Medone Ultra, Medextra Medax Srl Unipersonale KNW Class II 2020-04-02
K192099 MED-I Bone Marrow Aspiration Needle, MED-S Bone Marrow Aspiration Needle, MED-L Bone Marrow Biopsy and Aspiration System, MED-B Bone Marrow Biopsy System, MED-J Bone Marrow Biopsy and Aspiration System Medax Srl Unipersonale KNW Class II 2020-04-02
K193095 Ambu aScope 4 Cysto Ambu A/S FAJ Class II 2020-04-02
K200278 CytoCore Praxis Medical, LLC KNW Class II 2020-03-31
K200556 AquaFlate Pre-Filled Sterile Water Syringe 10mL H R Pharmaceuticals, Inc. EZL Class II 2020-03-31
K200741 Tablo Hemodialysis System Outset Medical, Inc. KDI Class II 2020-03-31
K183086 da Vinci X and Xi Surgical System Intuitive Surgical, Inc. NAY Class II 2020-03-31
K173590 System 83 Plus Washer/Disinfector Custom Ultrasonics, Inc. FEB Class II 2020-03-30
K191900 Single Use Grasping Forceps Zhejiang Chuangxiang Medical Technology Co., Ltd. OCZ Class II 2020-03-27
K193652 AbClose - Port Site Closure Device Medeon Biodesign, Inc. OCW Class II 2020-03-26
K192300 EnlightenVue Microendoscopy System Enlightenvue, Inc. GCJ Class II 2020-03-20
K192905 Creo Electrosurgical System with HS1 Hemostasis Accessory Creo Medical, Ltd. KNS Class II 2020-03-19
K193482 PrisMax System Version 3 Baxter Healthcare Corporation KDI Class II 2020-03-13
K193325 Avantgarde Faecal Management Systems, Avantgarde Faecal Management System Replacement Pouches Prosys International, Ltd. KNT Class II 2020-03-13
K193612 AMT Suture Delivery System Applied Medical Technology, Inc. KGC Class II 2020-03-12
K200049 Senhance Surgical System Transenterix, Inc. NAY Class II 2020-03-09
K200310 1688 Pendulum 4K Camera Head with Integrated Coupler, 1688 4K Camera Control Unit with Advanced Imaging Modality Stryker GCJ Class II 2020-03-06
K190527 GlidePath Long-Term Hemodialysis Catheters, HemoStar Long-Term Hemodialysis Catheters, HemoStar XK Long-Term Hemodialysis Catheters C. R. Bard MSD Class II 2020-03-05
K192697 Instinct Plus Endoscopic Clipping Device Cook Endoscopy PKL Class II 2020-03-05
K193416 Cellvizio I.V.E. with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2020-02-28
K192876 INTELLIO Tablet Application Smith & Nephew ODA Class II 2020-02-27
K200247 Fusion Quattro Extraction Balloon Wilson-Cook Medical, Inc. GCA Class II 2020-02-27
K193268 APrioCore Plus Apriomed AB KNW Class II 2020-02-27
K190032 Disposable Sclerotherapy Needle Hangzhou AGS MedTech Co., Ltd. FBK Class II 2020-02-27
DEN190020 iTind System Medi-Tate , Ltd. QKA Class II 2020-02-25
K192756 Aquadex FlexFlow System 2.0 Chf Solutions, Inc. KDI Class II 2020-02-24
K191474 NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton) Fresenius Medical Care Renal Therapies Group, LLC KPO Class II 2020-02-24
K192691 PatCom Single-Use Introducer H&A Mui Enterprises, Inc. FED Class II 2020-02-21
K192918 Video Laparoscope, Video Processor, Light Source Fujifilm Corporation GCJ Class II 2020-02-20
K200228 ClearCam System Clearcam, LLC GCJ Class II 2020-02-19
K192662 CapsoCam Plus (SV-3) Capsule Endoscopy System CapsoVision, Inc. NEZ Class II 2020-02-14
K191529 da Vinci Xi Surgical System, da Vinci X Surgical System Intuitive Surgical NAY Class II 2020-02-06
K191330 Arc Enterocuff Boddingtons Plastics, Ltd. FDA Class II 2020-01-31
K191254 EndoClot Endoclot Plus Co., Ltd. PLL Class II 2020-01-30
K192339 TeslaTome Bipolar Sphincterotome, Tesla Bipolar Active Cord Wilson-Cook Medical, Inc. KNS Class II 2020-01-30
K191472 Biopsy Needle Ushare Medical, Inc. FCG Class II 2020-01-29
K191715 Endoscope Tip Protector - Sterile, Endoscope Tip Protector - Non-sterile STERIS Corporation OCU Class II 2020-01-27
K193315 Xenocor Articulating Xenoscope Laparoscope Xenocor, Inc. GCJ Class II 2020-01-27
K191144 Cellvizio 100 Series System with Confocal Miniprobes Mauna Kea Technologies OWN Class II 2020-01-24
K191093 Isopure Dry Acid Dissolution System Isopure, Corp. KPO Class II 2020-01-22
K192684 HydroPearl Microspheres MicroVention, Inc. NOY Class II 2020-01-22
K192302 Mahurkar Acute Single Lumen Catheter, Mahurkar Acute Dual Lumen Catheter, Mahurkar Acute Triple Lumen Catheter, Mahurkar Acute High Pressure Triple Lumen Catheter Covidien, LLC MPB Class II 2020-01-17
K193182 Evis Exera III Duodenovideoscope Olympus TJF-Q190V Olympus Medical Systems Corp. FDT Class II 2020-01-17
K192869 SherpaPak Lung Preservation System , SherpaPak Liver Transport System Pragonix Technologies KDN Class II 2020-01-16
K192357 INNOVO Atlantic Therapeutics, Ltd. QAJ Class II 2020-01-16
K191678 IP Converter Sony Electronics, Inc. GCJ Class II 2020-01-10
K193137 EASYGRIP FLO-41 Precision MIS Delivery System Baxter Healthcare Corportation GCJ Class II 2020-01-08
K190669 Endotics Era Endoscopy S.R.L. FDF Class II 2020-01-03
K191061 Optilume Basic Urological Balloon Dilation Catheter Urotronic, Inc. KOE Class II 2020-01-02
K191446 Ureteral Stent Systems, Biliary Drainage Catheters Boston Scientific Corporation FAD Class II 2020-01-02
K192258 Disposable Valve Sets Zhejiang Chuangxiang Medical Technology Co., Ltd. ODC Class II 2019-12-30
DEN180067 Mucosal Integrity Conductivity (MI) Test System Diversatek Healthcare, Inc. QIS Class II 2019-12-23
K193235 Telepack + Karl Storz Endoscopy America, Inc. FET Class II 2019-12-20
K190805 PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL Pentax of America, Inc. PEA Class II 2019-12-20
K191440 Paragonix SherpaPak Pancreas Transport System Paragonix Technologies KDN Class II 2019-12-20
K193269 UroLift System (UL400) Neotract, Inc. PEW Class II 2019-12-20
K190829 Gastrointestinal Injection Needles (VIN, LDVI, DVI and MHI) Wilson-Cook Medical Inc./Cook Endoscopy FBK Class II 2019-12-19
K191087 IntraMarX Radiopaque Markers Anx Robotica Corp FFX Class II 2019-12-18
K193039 Single Use Balloon Dilator V (with knife) Olympus Medical Systems Corp. KNS Class II 2019-12-17
K193148 VaPro Plus Pocket, VaPro Plus Hollister Incorporated GBM Class II 2019-12-13
K193344 Tri-Ex Extraction Balloon with Multiple Sizing Wilson-Cook Medical, Inc. GCA Class II 2019-12-13
K193202 EXALT Model D Single-Use Duodenoscope, EXALT Controller Boston Scientific Corporation FDT Class II 2019-12-13
K190793 Tablo Hemodialysis System, Tablo Cartridge Outset Medical, Inc. KDI Class II 2019-12-12
K193123 FUJIFILM Distal Cap Models 33-40 Fujifilm Corporation FDS Class II 2019-12-11
K190612 EQUINOX Balloon Dilatation Catheter Dornier Medtech America, Inc. EZN Class II 2019-12-06
K191759 Medline Quick Switch Valve with ENFit Connector Medline Industries, Inc. PIF Class II 2019-12-04
K191379 RELiZORB Alcresta Therapeutics, Inc. PLQ Class II 2019-12-04
K190659 Ureteral Stent Open Tip/Closed Tip/Intraoperative Tip, Ureteral Stent via Ureterorenoscope Open Tip/Closed Tip, Pediatric Ureteral Stent Open Tip/Closed Tip, Mono J Urinary Diversion Ureteral Stent Open Tip/Closed Tip, Multiloop Ureteral Stent Open Tip/Closed Tip Allwin Medical Devices, Inc. FAD Class II 2019-12-02
K192468 Male, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Femal, Nelaton-tip Ready-to-Use Hydrophilic Catheter; Pediatric, Nelaton-tip Ready-to-Use Hydrophilic Catheter Intermittent Catheter; Male, Tapered-Tip Tiemann Ready-to-Use Hydrophilic Catheter; Male, Olive-Tip Tiemann Ready-to-Use Hydrophilic Catheter Hangzhou Bever Medical Devices Co., Ltd. GBM Class II 2019-11-27
K191851 VS3-IR Medtronic OWN Class II 2019-11-25
K190512 SmartBand EMR Kit, SmartBand EMR Pack, SmartSnare Intelligent Endoscopy FDI Class II 2019-11-22
K193036 C2 CryoBalloon EndoGrip Pentax Medical, A Division of Pentax of America, Inc. OCX Class II 2019-11-22
K190977 Navina Smart System, Navina Classic System Dentsply Sirona KNT Class II 2019-11-22
K192877 Senhance Surgical System Transenterix, Inc. NAY Class II 2019-11-22
K192664 FUJIFILM Endoscope Model EC-760Z-V/L Fujifilm Corporation FDF Class II 2019-11-20
DEN180062 EchoTip Insight Portosystemic Pressure Gradient Measuring System Cook Ireland, Ltd. QIJ Class II 2019-11-20
K192292 L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable Stryker OWN Class II 2019-11-19
K192643 Dannik Laparoscopic Suction Irrigation System Dannik GCJ Class II 2019-11-19
K192245 Pentax Medical Video Duodenoscope ED34-i10T2 Pentax of America, Inc. FDT Class II 2019-11-15
K190312 Dornier Ureteral Stent Dornier Medtech America, Inc. FAD Class II 2019-11-15
K192174 SPY Portable Handheld Imaging (SPY-PHI) System Novadaq Technologies Ulc. (Now A Part of Stryker) OWN Class II 2019-11-15
K191784 Gabriel Feeding Tube with Balloon, and EnFit Connector Syncro Medical Innovations, Inc. PIF Class II 2019-11-15
K192908 Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brushes Wilson-Cook Medical, Inc. FDX Class II 2019-11-14
K191280 E-100 Electrosurgical Generator, SynchroSeal Intuitive Surgical, Inc. NAY Class II 2019-11-14
K190799 PENTAX Medical Video Upper GI Scopes (EG Family) Pentax of America, Inc. FDS Class II 2019-11-12
K191282 PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family Pentax of America, Inc. PEA Class II 2019-11-08

11,341 clearances in the Gastroenterology, Urology panel. Data: openFDA.