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

9870
Total
9823
Cleared
154d
Avg (2y)
1976
Since
5370 Gastroenterology & Urology devices
2326–2350 of 5370
Cleared Jan 14, 2004
BARD ELIMINATOR PET BALLOON DILATORS
K033936 · C.R. Bard, Inc.
KNQ · Dilator, Esophageal · 26d
Cleared Jan 12, 2004
OPTICAL DVS (DUAL VECTOR SHEARING) ESOPHAGEAL DILATOR
K031147 · Ethicon Endo-Surgery, Inc.
KNQ · Dilator, Esophageal · 277d
Cleared Jan 02, 2004
OMNILINK .018 BILIARY STENT SYSTEM
K033834 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 23d
Cleared Dec 30, 2003
TRACER METRO SMART WIRE GUIDE
K033754 · Wilson-Cook Medical, Inc.
OCY · Endoscopic Guidewire, Gastroenterology-urology · 29d
Cleared Dec 30, 2003
MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT
K033778 · C.R. Bard, Inc.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 26d
Cleared Dec 23, 2003
INTERMITTENT URETHRAL CATHETERS
K033023 · Rusch Intl.
KOD · Catheter, Urological · 88d
Cleared Dec 22, 2003
CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K033394 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 60d
Cleared Dec 19, 2003
WILSON-COOK TRI-TOME SELECT PLUS
K033203 · Wilson-Cook Medical, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 78d
Cleared Dec 17, 2003
STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITS
K032943 · Stryker Corp.
KNW · Instrument, Biopsy · 86d
Cleared Dec 15, 2003
ZILVER 518 BILIARY STENT
K033348 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 56d
Cleared Dec 12, 2003
FASTRAC GASTRIC ACCESS PORT KIT
K033562 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 30d
Cleared Dec 10, 2003
SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005
K033537 · Abbott Laboratories
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Dec 08, 2003
GYNECARE TVT OBTURATOR SYSTEM
K033568 · Ethicon, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 26d
Cleared Nov 26, 2003
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 43d
Cleared Nov 26, 2003
NXSTAGE PUREFLOW SOLUTION
K033386 · Nxstage Medical, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 34d
Cleared Nov 25, 2003
LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS
K033335 · Siemens Medical Solutions USA, Inc.
MMZ · Table, Cystometric, Electric · 40d
Cleared Nov 21, 2003
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM
K033314 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 37d
Cleared Nov 20, 2003
HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q
K031676 · Baxter Healthcare Corp
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 174d
Cleared Nov 17, 2003
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM
K033134 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 48d
Cleared Nov 14, 2003
BARD DUAL LUMEN URETERAL CATHETER
K032521 · C.R. Bard, Inc.
EYB · Catheter, Ureteral, Gastro-urology · 91d
Cleared Nov 10, 2003
ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM
K033393 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 18d
Cleared Nov 06, 2003
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K033245 · C.R. Bard, Inc.
MND · Ligator, Esophageal · 30d
Cleared Oct 29, 2003
AMSURE FOLEY CATHETER
K030120 · Amsino International, Inc.
EZL · Catheter, Retention Type, Balloon · 289d
Cleared Oct 29, 2003
GIVEN DIAGNOSTIC SYSTEM
K032405 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 86d
Cleared Oct 28, 2003
NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS
K032356 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 90d

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All categories 5370 FGE Stents, Drains And Dilators For The Biliary Ducts 314 KNT Tubes, Gastrointestinal (and Accessories) 301 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 217 KOD Catheter, Urological 129 KNW Instrument, Biopsy 122 KOC Accessories, Blood Circuit, Hemodialysis 121 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 116 FJI Dialyzer, Capillary, Hollow Fiber 96 FAD Stent, Ureteral 94 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 92 FGB Ureteroscope And Accessories, Flexible/rigid 89 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 81 FDF Colonoscope And Accessories, Flexible/rigid 71 EXB Collector, Ostomy 68 FED Endoscopic Access Overtube, Gastroenterology-urology 67