FDA Review Panel · GU

FDA 510(k) Gastroenterology & Urology Devices

FDA 510(k) Gastroenterology & Urology Devices - Regulatory Overview

FDA 510(k) gastroenterology and urology devices cover diagnostic and interventional equipment for the GI tract and urinary system. The FDA review panel code is GU.

Common device types:

  • GI endoscopes - gastroscopes, colonoscopes, duodenoscopes and capsule endoscopy
  • Biliary and pancreatic stents - metal and plastic biliary drainage devices
  • Urological devices - ureteral stents, catheters, stone retrieval baskets
  • Ablation systems - RFA and cryoablation for GI lesions
  • Anorectal devices - manometry systems, hemorrhoid treatment

9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8381 Gastroenterology & Urology devices
1901–1925 of 8381
Cleared Oct 08, 2015
Single Use Balloon Dilator V (with Knife)
K150142 · Olympus Medical Systems Corp.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 259d
Cleared Oct 06, 2015
AXIOS Stent and Delivery System
K152572 · Boston Scientific Corporation
PCU · Pancreatic Stent, Covered, Metallic, Removable · 27d
Cleared Oct 01, 2015
EPX-4440HD and EPX-4400HD with FICE
K150221 · Fujifilm Medical System U.S.A., Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 244d
Cleared Sep 30, 2015
Entuit Secure Gastrointestinal Suture Anchor Set, Entuit Secure Adjustable Gastrointestinal Suture Anchor Set
K152524 · Cook Incorporated
FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d
Cleared Sep 24, 2015
Exodus Array Multipurpose Drainage Catheter, Exodus Nuance Nephrostomy Drainage Catheter, Exodus Believe Biliary Drainage Catheter
K152069 · Navilyst Medical, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 59d
Cleared Sep 23, 2015
UPT Series Medical RO Water System
K151637 · Specialty Water Technologies
FIP · Subsystem, Water Purification · 98d
Cleared Sep 21, 2015
Phoenix XL Dialysate Meter
K150657 · Mesa Laboratories, Inc.
FIZ · Meter, Conductivity, Non-remote · 192d
Cleared Sep 18, 2015
CoStorSol plus G
K151728 · Preservation Solutions, Inc.
KDN · System, Perfusion, Kidney · 84d
Cleared Sep 17, 2015
Radifocus Glidewire Endoscopic Wire
K151471 · Terumo Medical Corporation
OCY · Endoscopic Guidewire, Gastroenterology-urology · 108d
Cleared Sep 16, 2015
OTSC Proctology
K150067 · Ovesco Endoscopy AG
PKL · Hemostatic Metal Clip For The Gi Tract · 246d
Cleared Sep 11, 2015
Spectra Optia Apheresis System, Spectra Optia Exchange Set (with AC Connection), Spectra Optia AC Connection Adapter
K151368 · Terumo Bct
LKN · Separator, Automated, Blood Cell And Plasma, Therapeutic · 113d
Cleared Sep 11, 2015
AQUA CLEANSE
K150381 · Quality Medical Supply, Inc.
KPL · Colonic Irrigation System · 205d
Cleared Sep 09, 2015
VAPRO PLUS POCKET Intermittent Catheter
K152268 · Hollister Incorporated
GBM · Catheter, Urethral · 29d
Cleared Sep 03, 2015
SIC 8000
K150852 · Cosmo Technologies, Ltd.
PLL · Submucosal Injection Agent · 156d
Cleared Sep 03, 2015
Peristeen Anal Irrigation System
K140310 · Coloplast A/S
KNT · Tubes, Gastrointestinal (and Accessories) · 573d
Cleared Aug 27, 2015
Rezum System
K150786 · Nxthera, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 155d
Cleared Aug 25, 2015
BioGuard Air/Water Valve, BioGuard Suction Valve
K151345 · United States Endoscopy Group, Inc.
ODC · Endoscope Channel Accessory · 98d
Cleared Aug 20, 2015
STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]
K151243 · Stryker Endoscopy
FCS · Light, Catheter, Fiberoptic, Glass, Ureteral · 101d
Cleared Aug 20, 2015
Fujifilm Double Balloon Endoscopes Models EN-530T and EN-580T
K143556 · Fujifilm Medical Systems U.S.A, Inc.
FDA · Enteroscope And Accessories · 248d
Cleared Aug 14, 2015
Sertera Biopsy Device
K150169 · Hologic, Inc.
KNW · Instrument, Biopsy · 200d
Cleared Aug 13, 2015
Arc Endocuff Vision
K151801 · Boddingtons Plastics, Ltd.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 42d
Cleared Aug 07, 2015
Corvocet Coaxial Introducer
K151373 · Merit Medical Systems, Inc.
FCG · Biopsy Needle · 78d
Cleared Aug 06, 2015
Resolution Clip
K151802 · Boston Scientific Corporation
PKL · Hemostatic Metal Clip For The Gi Tract · 35d
Cleared Aug 05, 2015
AXIOS Stent with Electrocautery Enhanced Delivery System
K150692 · Boston Scientific Corp
PCU · Pancreatic Stent, Covered, Metallic, Removable · 140d
Cleared Jul 30, 2015
Infinity ERCP Sampling Device
K151889 · United States Endoscopy Group, Inc.
FDX · Endoscopic Cytology Brush · 20d

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All categories 8381 KNT Tubes, Gastrointestinal (and Accessories) 524 FGE Stents, Drains And Dilators For The Biliary Ducts 460 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 329 KNW Instrument, Biopsy 279 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 168 KOD Catheter, Urological 163 KOC Accessories, Blood Circuit, Hemodialysis 145 MSD Catheter, Hemodialysis, Implanted 124 EZL Catheter, Retention Type, Balloon 119 FJI Dialyzer, Capillary, Hollow Fiber 119 FAD Stent, Ureteral 113 FGB Ureteroscope And Accessories, Flexible/rigid 112 FDF Colonoscope And Accessories, Flexible/rigid 111 FIP Subsystem, Water Purification 105 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104