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
2611 Gastroenterology & Urology devices
1651–1675 of 2611
Cleared Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K091816 · Boston Scientific Corporation
ESW · Prosthesis, Esophageal · 13d
Cleared Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
K091510 · Boston Scientific Corporation
ESW · Prosthesis, Esophageal · 35d
Cleared Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
K091340 · Boston Scientific Corp
FPD · Tube, Feeding · 34d
Cleared May 29, 2009
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
K083598 · KARL STORZ Endoscopy-America, Inc.
ODA · Endoscopic Central Control Unit · 175d
Cleared May 28, 2009
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
K090528 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 90d
Cleared Apr 22, 2009
WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM
K083374 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 160d
Cleared Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · Merit Medical Systems, Inc.
MSD · Catheter, Hemodialysis, Implanted · 82d
Cleared Apr 07, 2009
WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540
K083627 · Boston Scientific Corporation
FGE · Stents, Drains And Dilators For The Biliary Ducts · 120d
Cleared Mar 19, 2009
POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER
K083675 · C.R. Bard, Inc.
NIE · Catheter, Hemodialysis, Triple Lumen, Non-implanted · 98d
Cleared Feb 20, 2009
CONNEX GASTROINTESTINAL SUTURE ANCHOR, MODEL GIAS
K090133 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Feb 12, 2009
NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
K090102 · C.R. Bard, Inc.
MPB · Catheter, Hemodialysis, Non-implanted · 28d
Cleared Feb 10, 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 26d
Cleared Feb 04, 2009
SPYSCOPE ACCESS AND DELIVERY CATHETER
K090170 · Boston Scientific Corp
ODF · Mini Endoscope, Gastroenterology-urology · 12d
Cleared Dec 18, 2008
XENON-100 SCB LIGHT SOURCE, MODEL 20132620
K082925 · KARL STORZ Endoscopy-America, Inc.
GCT · Light Source, Endoscope, Xenon Arc · 78d
Cleared Dec 03, 2008
2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT
K081739 · Boston Scientific Corp
KNT · Tubes, Gastrointestinal (and Accessories) · 167d
Cleared Nov 25, 2008
ENTERAL ONLY EXTENSION SET
K082654 · Respironics, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 74d
Cleared Oct 27, 2008
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929
K082464 · Medtronic, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 61d
Cleared Oct 27, 2008
10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890
K081733 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 130d
Cleared Oct 23, 2008
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K080944 · C.R. Bard, Inc.
LJE · Catheter, Nephrostomy · 203d
Cleared Oct 15, 2008
VACORA VACUUM ASSISTED BIOPSY SYSTEM
K082681 · C.R. Bard, Inc.
KNW · Instrument, Biopsy · 30d
Cleared Oct 10, 2008
KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
K082046 · KARL STORZ Endoscopy-America, Inc.
FBO · Cystourethroscope · 84d
Cleared Sep 05, 2008
POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330
K080332 · Boston Scientific Corporation
ESW · Prosthesis, Esophageal · 211d
Cleared Aug 27, 2008
BOSTON SCIENTIFIC SURGICAL MESH
K081275 · Boston Scientific Corp
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 114d
Cleared Aug 01, 2008
MODIFICATION TO ZILVER 635 BILIARY STENT
K080037 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 207d
Cleared Jul 18, 2008
ASPIRA PERITONEAL DRAINAGE SYSTEM
K081288 · C.R. Bard, Inc.
PNG · Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling · 72d

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All categories 2611 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