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

9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2604 Gastroenterology & Urology devices
1576–1600 of 2604
Cleared Jun 18, 2014
CENTROS LONG TERM HEMODIALYSIS CATHETER, CENTROSFLO LONG TERM HEMODIALYSIS CATHETER
K141363 · Merit Medical Systems, Inc.
MSD · Catheter, Hemodialysis, Implanted · 26d
Cleared Jun 11, 2014
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K141250 · KARL STORZ Endoscopy-America, Inc.
FGB · Ureteroscope And Accessories, Flexible/rigid · 28d
Cleared May 14, 2014
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
K133700 · Boston Scientific Corporation
FGE · Stents, Drains And Dilators For The Biliary Ducts · 162d
Cleared May 09, 2014
BARD DIGNISHIELD STOOL MANAGEMENT SYSTEM
K133251 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 199d
Cleared Apr 04, 2014
BARD RITECATH INTERMITTENT CATHETER
K133470 · C.R. Bard, Inc.
EZD · Catheter, Straight · 143d
Cleared Apr 02, 2014
INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER
K133933 · Boston Scientific Corporation
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 100d
Cleared Mar 12, 2014
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM
K130981 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 337d
Cleared Feb 21, 2014
MEDLINE BIOPSY VALVE
K131426 · Medline Industries, Inc.
OCX · Endoscopic Irrigation/suction System · 280d
Cleared Jan 24, 2014
CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES
K133987 · Boston Scientific Corporation
FDI · Snare, Flexible · 29d
Cleared Jan 08, 2014
OCCLUDER OCCLUSION BALLOON CATHETER
K133750 · Boston Scientific Corporation
EYB · Catheter, Ureteral, Gastro-urology · 30d
Cleared Jan 03, 2014
EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K133312 · Boston Scientific Corporation
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 67d
Cleared Jan 02, 2014
FLEXIBLE CMOS-VIDEO-CYSTO-URETHROSCOPE
K131364 · KARL STORZ Endoscopy-America, Inc.
FBO · Cystourethroscope · 234d
Cleared Dec 20, 2013
IMAGE1 SPIES
K131953 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 176d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · Boston Scientific Corporation
ESW · Prosthesis, Esophageal · 338d
Cleared Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · KARL STORZ Endoscopy-America, Inc.
FGB · Ureteroscope And Accessories, Flexible/rigid · 197d
Cleared Nov 04, 2013
SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES
K131700 · Boston Scientific Corp
FDI · Snare, Flexible · 146d
Cleared Oct 07, 2013
ENTUIT SECURE GASTROINTESTIONAL SUTURE ANCHOR SET, ENTUIT SECURE ADJUSTABLE GASTROINTESTINAL SUTURE ANCHOR SET
K131201 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 161d
Cleared Sep 18, 2013
MEDLINE ANTI-REFLUX VALVE
K132314 · Medline Industries, Inc.
FEG · Tube, Double Lumen For Intestinal Decompression And/or Intubation · 55d
Cleared Aug 30, 2013
LIFESTENT BILIARY STENT SYSTEM, LIFESTENT XL BILIARY STENT SYSTEM
K130792 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 161d
Cleared Aug 23, 2013
GYNECARE TVT EXACT CONTINENCE SYSTEM
K132054 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 51d
Cleared Aug 09, 2013
MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER
K130484 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 165d
Cleared Jul 29, 2013
COOK TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY COOK SPECTRUM TURBO-FLO HD ACUTE HEMODIALYSIS CATHETER SET/TRAY
K122091 · Cook, Inc.
MPB · Catheter, Hemodialysis, Non-implanted · 378d
Cleared May 22, 2013
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation
EZN · Dilator, Catheter, Ureteral · 58d
Cleared May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
K130909 · Boston Scientific Corp
OCX · Endoscopic Irrigation/suction System · 45d
Cleared Apr 03, 2013
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
K130423 · Richard Wolf Medical Instruments Corp.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 42d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 2604 FGE Stents, Drains And Dilators For The Biliary Ducts 185 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 73 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 70 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 48 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 47 OCX Endoscopic Irrigation/suction System 44 KNW Instrument, Biopsy 43 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 40