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
5372 Gastroenterology & Urology devices
2501–2525 of 5372
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
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH SPLIT-CATH, 14FX36CM ASH SPLIT-CATH, 14F X 40CM ASH
K013162 · Medcomp
KNT · Tubes, Gastrointestinal (and Accessories) · 28d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · Wilson-Cook Medical, Inc.
FCG · Biopsy Needle · 9d
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 Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
K012949 · Sofradim Production
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 30d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · Medcomp
MSD · Catheter, Hemodialysis, Implanted · 244d
Cleared Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · Medical Components, Inc.
MSD · Catheter, Hemodialysis, Implanted · 667d
Cleared Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
K011800 · Vanguard Medical Concepts, Inc.
NLU · Forceps, Biopsy, Electric, Reprocessed · 111d
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 12, 2001
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · Senorx, Inc.
KNW · Instrument, Biopsy · 76d
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 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc.
GBM · Catheter, Urethral · 28d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · Boston Scientific Scimed, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 32d
Cleared Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS HEMODIALYSIS BLOOD TUBING SETS
K012242 · Fresenius Medical Care North America
FJK · Set, Tubing, Blood, With And Without Anti-regurgitation Valve · 30d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 200d
Cleared Aug 10, 2001
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS, ATTCHEMENTS, AND FORCEPS MODEL 8650, 8652, 8660
K011496 · Richard Wolf Medical Instruments Corp.
FBO · Cystourethroscope · 87d
Cleared Aug 01, 2001
SPARC SLING SYSTEM
K011251 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 99d
Cleared Aug 01, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Not Cleared Aug 01, 2001
GIVEN DIAGNOSTIC IMAGING SYSTEM
DEN010002 · Given Imaging , Ltd.
NEZ · System, Imaging, Gastrointestinal, Wireless, Capsule · 51d
Cleared Jul 25, 2001
DRAINAGE CATHETER OR FOLEY CATHETER
K010006 · Applied Medical Resources Corp.
EZL · Catheter, Retention Type, Balloon · 204d
Cleared Jul 18, 2001
DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K011881 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d

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All categories 5372 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 129 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 KDJ Set, Administration, For Peritoneal Dialysis, Disposable 94 FAD Stent, Ureteral 94 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