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
2617 Gastroenterology & Urology devices
1701–1725 of 2617
Cleared Jan 05, 2007
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
K063632 · C.R. Bard, Inc.
LJE · Catheter, Nephrostomy · 30d
Cleared Dec 15, 2006
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K063446 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 30d
Cleared Dec 04, 2006
WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030
K062750 · Boston Scientific Corp
MUM · Stent, Metallic, Expandable, Duodenal · 81d
Cleared Nov 09, 2006
KARL STORZ VIDEO GASTROSCOPES
K060907 · KARL STORZ Endoscopy-America, Inc.
FDS · Gastroscope And Accessories, Flexible/rigid · 220d
Cleared Oct 20, 2006
VACORA 14G BIOPSY PROBES, MODELS VB14116, VB14138
K062832 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 29d
Cleared Sep 21, 2006
MAXFORCE TTS SINGLE-USE BALLOON DILATOR
K061787 · Boston Scientific Corp
KNQ · Dilator, Esophageal · 87d
Cleared Sep 15, 2006
WALLFLEX ENTERAL COLONIC STENT WITH ANCHOR LOCK DELIVERY SYSTEM
K061877 · Boston Scientific Corp
MQR · Stent, Colonic, Metallic, Expandable · 74d
Cleared Sep 11, 2006
RENALSOFT
K061515 · Baxter Healthcare Corp
KPF · System, Dialysate Delivery, Semi-automatic, Peritoneal · 102d
Cleared Sep 01, 2006
WELLFLEX BILIARY RX STENT SYSTEM
K061231 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 122d
Cleared Aug 18, 2006
FOLEY CATHETERS WITH TEMPERATURE PROBE
K061918 · Ge Healthcare
EYC · Catheter, Upper Urinary Tract · 43d
Cleared May 12, 2006
ULTRAFLEX PRECISION COLONIC STENT, MODELS M00557330, MO00557360, M00557380
K060323 · Boston Scientific Corporation
MQR · Stent, Colonic, Metallic, Expandable · 92d
Cleared Apr 27, 2006
PALMAZ BLUE .014 TRANSHEPATIC BILIARY STENT SYSTEM-MODEL PB1550,BAS,BAX,PB1560,BAS,BAX,PB1850,BAS,BAXPB1860BAS,BAX
K060877 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 27d
Cleared Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310
K053512 · Baxter Healthcare Corp
FKX · System, Peritoneal, Automatic Delivery · 62d
Cleared Feb 16, 2006
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
K052168 · Medline Industries, Inc.
EZL · Catheter, Retention Type, Balloon · 191d
Cleared Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
K052539 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 85d
Cleared Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
K052401 · Ethicon, Inc.
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 88d
Cleared Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
K052413 · Medtronic Vascular
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 76d
Cleared Nov 09, 2005
B. BRAUN MODIFIED BICARBONATE DIALYSATE
K052393 · B.Braun Medical, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 70d
Cleared Oct 28, 2005
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · Richard Wolf Medical Instruments Corp.
OCZ · Endoscopic Grasping/cutting Instrument, Non-powered · 164d
Cleared Oct 05, 2005
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
K051176 · Richard Wolf Medical Instruments Corp.
FAJ · Cystoscope And Accessories, Flexible/rigid · 152d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · Boston Scientific Corp
ODF · Mini Endoscope, Gastroenterology-urology · 13d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 53d
Cleared Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 44d
Cleared Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316 · C.R. Bard, Inc.
LJE · Catheter, Nephrostomy · 59d
Cleared Jul 12, 2005
ZILVER 635 BILIARY STENT
K051124 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 70d

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All categories 2617 FGE Stents, Drains And Dilators For The Biliary Ducts 186 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 74 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