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
5367 Gastroenterology & Urology devices
2001–2025 of 5367
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 Jun 05, 2009
EXALIS, SOFTWARE VERSION 1.15
K083158 · Gambro, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 224d
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 May 07, 2009
VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM, MODEL 50020
K091152 · Coloplast A/S
OTM · Mesh, Surgical, For Stress Urinary Incontinence, Male · 17d
Cleared Apr 23, 2009
BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070
K090217 · Coloplast A/S
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 84d
Cleared Apr 22, 2009
FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15
K090116 · Fujinon, Inc.
FDF · Colonoscope And Accessories, Flexible/rigid · 91d
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 20, 2009
MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565
K090814 · Gyrus Acmi, Inc.
FAJ · Cystoscope And Accessories, Flexible/rigid · 26d
Cleared Apr 13, 2009
PROGUIDE CHRONIC DIALYSIS CATHETER
K090148 · Merit Medical Systems, Inc.
MSD · Catheter, Hemodialysis, Implanted · 82d
Cleared Apr 09, 2009
AMS SPECTRA CONCEALABLE PENILE PROSTHESIS
K090663 · American Medical Systems, Inc.
FAE · Prosthesis, Penile · 28d
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 20, 2009
XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210
K083778 · Baxter Healthcare Corporation
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 63d
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
BLOOD TUBING SETS (STERILE FLUID PATH)
K090255 · Nxstage Medical, Inc.
FJK · Set, Tubing, Blood, With And Without Anti-regurgitation Valve · 8d
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 Feb 04, 2009
ACTIFLO INDWELLING BOWEL CATHETER SYSTEM KIT, MODELS: 32004, 32005, 32006, 32007
K083153 · Hollister, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 103d
Cleared Jan 14, 2009
FRESENIUS MODEL 2008T HEMODIALYSIS MACHINE
K080964 · Fresenius Medical Care North America
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 285d
Cleared Jan 13, 2009
HD CAMERA HEAD OTV-S7PROH-HD-L08E
K083155 · Olympus Medical Systems Corporation
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 81d
Cleared Dec 29, 2008
FRESENIUS STERILE STAY SAFE CAP
K083542 · Fresenius Medical Care North America
KDJ · Set, Administration, For Peritoneal Dialysis, Disposable · 31d
Cleared Dec 19, 2008
STRYKER LED LIGHTSOURCE
K082813 · Stryker Corp.
FCW · Light Source, Fiberoptic, Routine · 86d

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All categories 5367 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 128 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 91 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