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
5369 Gastroenterology & Urology devices
2226–2250 of 5369
Cleared Mar 30, 2005
MODIFICATION TO:ZILVER 518 BILIARY STENT
K050698 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 13d
Cleared Mar 22, 2005
LIFESTENT TURBO BILIARY STENT SYSTEMS
K050627 · Edwards Lifesciences, LLC
FGE · Stents, Drains And Dilators For The Biliary Ducts · 11d
Cleared Mar 18, 2005
RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES
K042523 · Richard Wolf Medical Instruments Corp.
FJL · Resectoscope · 182d
Cleared Mar 17, 2005
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
K043436 · Nxstage Medical, Inc.
FKR · Subsystem, Proportioning · 94d
Cleared Mar 16, 2005
STRYKER URETEROSCOPE
K043021 · Stryker Endoscopy
FGB · Ureteroscope And Accessories, Flexible/rigid · 133d
Cleared Mar 15, 2005
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · Stryker Endoscopy
FAJ · Cystoscope And Accessories, Flexible/rigid · 132d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · Boston Scientific Corp
PID · Esophageal Dilator Balloon With Or Without Electrode Sensors · 38d
Cleared Mar 08, 2005
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · Conmedcorp
OCY · Endoscopic Guidewire, Gastroenterology-urology · 28d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · Boston Scientific Corp
ODF · Mini Endoscope, Gastroenterology-urology · 15d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · Abbott Laboratories
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Feb 11, 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · Medical Device Technologies, Inc.
KNW · Instrument, Biopsy · 53d
Cleared Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
K043414 · Health & Life Co., Ltd.
MNW · Analyzer, Body Composition · 58d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · Boston Scientific Corp
FCG · Biopsy Needle · 21d
Cleared Feb 03, 2005
MEDCOMP SPLIT-CATH II
K040318 · Medcomp
MSD · Catheter, Hemodialysis, Implanted · 360d
Cleared Jan 25, 2005
VANGUARD REPROCESSED NON-ELECTRIC BIOPSY FORCEPS
K042594 · Vanguard Medical Concepts, Inc.
NON · Forceps, Biopsy, Non-electric, Reprocessed · 124d
Cleared Jan 19, 2005
OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
K043060 · Omron Healthcare, Inc.
MNW · Analyzer, Body Composition · 75d
Cleared Dec 29, 2004
MODIFICATION TO: ZILVER 635 BILIARY STENT
K043481 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 14d
Cleared Dec 23, 2004
LIFESTENT NT35 BILIARY STENT SYSTEM
K042985 · Edwards Lifesciences, LLC
FGE · Stents, Drains And Dilators For The Biliary Ducts · 55d
Cleared Dec 23, 2004
LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER
K043241 · Astra Tech, Inc.
GBM · Catheter, Urethral · 30d
Cleared Dec 20, 2004
FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR
K043244 · Fresenius Medical Care North America
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 27d
Cleared Dec 16, 2004
MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02
K043258 · Teleflex Medical
KNT · Tubes, Gastrointestinal (and Accessories) · 22d
Cleared Dec 14, 2004
INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304
K042592 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 82d
Cleared Dec 10, 2004
KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE
K043114 · Kimberly-Clark Corp.
KNT · Tubes, Gastrointestinal (and Accessories) · 30d
Cleared Dec 09, 2004
PRIMUS STENT AND DELIVERY SYSTEM
K043243 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 16d
Cleared Dec 07, 2004
BARD INLAYOPTIMA URETERAL STENT WITH SUTURE
K043193 · C.R. Bard, Inc.
FAD · Stent, Ureteral · 19d

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All categories 5369 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 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