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

9917
Total
9869
Cleared
154d
Avg (2y)
1976
Since
8420 Gastroenterology & Urology devices
3351–3375 of 8420
Cleared Aug 30, 2005
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979 · O.R. Solutions, Inc.
OCT · Anti Fog Solution And Accessories, Endoscopy · 40d
Cleared Aug 29, 2005
UROPLASTY RIGID ENDOSCOPIC NEEDLE
K051905 · Uroplasty, Inc.
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 46d
Cleared Aug 25, 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
K052114 · Bard Peripheral Vascular, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 21d
Cleared Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132 · Edwards Lifesciences, LLC
FGE · Stents, Drains And Dilators For The Biliary Ducts · 19d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · Boston Scientific Corp
ODF · Mini Endoscope, Gastroenterology-urology · 13d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 53d
Cleared Aug 22, 2005
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
K050827 · Dialysis Solutions, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 143d
Cleared Aug 18, 2005
COLONIC AND ENEMA NOZZLE
K051344 · Ultimate Concepts, Inc.
KPL · Colonic Irrigation System · 87d
Cleared Aug 16, 2005
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · Acmi Corporation
FGB · Ureteroscope And Accessories, Flexible/rigid · 19d
Cleared Aug 15, 2005
MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3
K051613 · Olympus Medical Systems Corporation
ODA · Endoscopic Central Control Unit · 59d
Cleared Aug 12, 2005
HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS
K051748 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 44d
Cleared Aug 11, 2005
I-STOP
K051533 · Cl Medical
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 63d
Cleared Aug 05, 2005
OMNI SPHINCTEROTOME
K052051 · Wilson-Cook Medical, Inc.
KNS · Unit, Electrosurgical, Endoscopic (with Or Without Accessories) · 7d
Cleared Aug 04, 2005
JMS SYSLOC MINI A.V. FISTULA NEEDLE SET AND APHERESIS NEEDLE SET
K051814 · Jms North America Corp.
FIE · Needle, Fistula · 30d
Cleared Jul 27, 2005
MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY
K051506 · Sterylab S.R.L.
FCG · Biopsy Needle · 50d
Cleared Jul 27, 2005
SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000
K051581 · Sanarus Medical, Inc.
KNW · Instrument, Biopsy · 42d
Cleared Jul 26, 2005
MODIFICATION TO: USGI SHAPELOCK ENDOSCOPIC GUIDE
K051919 · Usgi Medical
FED · Endoscopic Access Overtube, Gastroenterology-urology · 11d
Cleared Jul 20, 2005
REPROCESSED COLD BIOPSY FORCEPS
K042648 · Sterilmed, Inc.
NON · Forceps, Biopsy, Non-electric, Reprocessed · 295d
Cleared Jul 20, 2005
REPROCESSED HOT BIOPSY FORCEPS
K050136 · Sterilmed, Inc.
NLU · Forceps, Biopsy, Electric, Reprocessed · 180d
Cleared Jul 18, 2005
X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER
K051316 · C.R. Bard, Inc.
LJE · Catheter, Nephrostomy · 59d
Cleared Jul 14, 2005
CONMED IRRIGATION NOZZLE
K050992 · Conmedcorp
KPL · Colonic Irrigation System · 86d
Cleared Jul 13, 2005
K-C HEMOSTATIC BIOPSY SYSTEM
K050135 · Bioengineering Consultants , Ltd.
FCG · Biopsy Needle · 173d
Cleared Jul 13, 2005
IMPEDIMED - BODY COMPOSITION ANALYSIS
K050395 · Impedimed Pty , Ltd.
MNW · Analyzer, Body Composition · 147d
Cleared Jul 12, 2005
ZILVER 635 BILIARY STENT
K051124 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 70d
Cleared Jul 11, 2005
ZUTRON COLONOSCOPE STIFFENING DEVICE
K051068 · Zutron Medical
FDF · Colonoscope And Accessories, Flexible/rigid · 76d

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All categories 8420 KNT Tubes, Gastrointestinal (and Accessories) 525 FGE Stents, Drains And Dilators For The Biliary Ducts 461 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 331 KNW Instrument, Biopsy 280 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 168 KOD Catheter, Urological 164 KOC Accessories, Blood Circuit, Hemodialysis 145 MSD Catheter, Hemodialysis, Implanted 124 EZL Catheter, Retention Type, Balloon 119 FJI Dialyzer, Capillary, Hollow Fiber 119 FAD Stent, Ureteral 113 FGB Ureteroscope And Accessories, Flexible/rigid 112 FDF Colonoscope And Accessories, Flexible/rigid 111 FIP Subsystem, Water Purification 106 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104