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
2625 Gastroenterology & Urology devices
1826–1850 of 2625
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · C.R. Bard, Inc.
MND · Ligator, Esophageal · 11d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON REPLACEMENT, MODELS 6520, 6521, 6220
K020120 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 200d
Cleared Jul 09, 2002
ENDOVIVE INITIAL PLACEMENT GASTROSTOMY KIT
K014297 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 190d
Cleared Jun 28, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
K021345 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 60d
Cleared May 02, 2002
VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA
K021074 · Olympus America, Inc.
FAJ · Cystoscope And Accessories, Flexible/rigid · 30d
Cleared Apr 12, 2002
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205 AND 4238
K020824 · Boston Scientific Corp
FHN · Ligator, Hemorrhoidal · 29d
Cleared Apr 12, 2002
MODIFICATION TO CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K020809 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Apr 02, 2002
BARD LUMINEXX 6 FR BILIARY STENT AND DELIVERY SYSTEM
K020682 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 34d
Cleared Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · Olympus America, Inc.
MND · Ligator, Esophageal · 90d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp
FKX · System, Peritoneal, Automatic Delivery · 90d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 162d
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 27d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 261d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 91d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp
FCG · Biopsy Needle · 58d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · Boston Scientific Corp
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 29d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 29d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · KARL STORZ Endoscopy-America, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 75d
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM, ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM
K012883 · Boston Scientific Corp
ESW · Prosthesis, Esophageal · 45d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
K011911 · Richard Wolf Medical Instruments Corp.
FFK · Lithotriptor, Electro-hydraulic · 90d
Cleared Sep 07, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY SYSTEM
K012590 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 196d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · Boston Scientific Corp
MSD · Catheter, Hemodialysis, Implanted · 29d

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All categories 2625 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 KNW Instrument, Biopsy 44 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 41