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
153d
Avg (2y)
1976
Since
2351 Gastroenterology & Urology devices
1776–1800 of 2351
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 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 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 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 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
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp
KOD · Catheter, Urological · 18d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 79d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · Boston Scientific Corp
ODD · Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula · 27d
Cleared Apr 13, 2001
NIAGARA SLIM-CATH
K010778 · C.R. Bard, Inc.
MPB · Catheter, Hemodialysis, Non-implanted · 29d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 30d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp
ODC · Endoscope Channel Accessory · 26d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 174d

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All categories 2351 FGE Stents, Drains And Dilators For The Biliary Ducts 155 KNT Tubes, Gastrointestinal (and Accessories) 110 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 74 FGB Ureteroscope And Accessories, Flexible/rigid 70 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 66 PKL Hemostatic Metal Clip For The Gi Tract 49 FED Endoscopic Access Overtube, Gastroenterology-urology 48 ODC Endoscope Channel Accessory 47 FAD Stent, Ureteral 45 FAJ Cystoscope And Accessories, Flexible/rigid 44 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDF Colonoscope And Accessories, Flexible/rigid 39 KNW Instrument, Biopsy 39