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
8431 Gastroenterology & Urology devices
4151–4175 of 8431
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 Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · Jms Co., Ltd.
FIE · Needle, Fistula · 400d
Cleared Sep 06, 2001
UROSCOPE, ARTES MEDICAL, USA
K003988 · Artes Medical USA, Inc.
FAJ · Cystoscope And Accessories, Flexible/rigid · 254d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873 · Dornier
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 77d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · Applied Medical Technology, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 29d
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 24, 2001
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
K012445 · Electro Medical Systems SA
FFK · Lithotriptor, Electro-hydraulic · 23d
Cleared Aug 23, 2001
RADIUS NEXT GENERATION GUIDEWIRE
K011759 · Radius Medical Technologies, Inc.
OCY · Endoscopic Guidewire, Gastroenterology-urology · 78d
Cleared Aug 23, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012347 · Sulzer Intratherapeutics, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Aug 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · Astra Tech, Inc.
GBM · Catheter, Urethral · 28d
Cleared Aug 22, 2001
BRIDGE FX
K011817 · Medtronic Ave, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 72d
Cleared Aug 22, 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · Ranfac, Corp.
KNW · Instrument, Biopsy · 67d
Cleared Aug 17, 2001
SPEEDYBELL
K010735 · Biopsybell S.A.S.
KNW · Instrument, Biopsy · 158d
Cleared Aug 17, 2001
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
K011575 · Imagyn Surgical
KNW · Instrument, Biopsy · 87d
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
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K011667 · Horizons Intl. Corp.
FDI · Snare, Flexible · 78d
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 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM)
K010399 · Diatek, Inc.
MSD · Catheter, Hemodialysis, Implanted · 186d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 200d
Cleared Aug 13, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K011184 · Intratherapeutics, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 117d
Cleared Aug 10, 2001
ROSS EMBRACE PUMP SET
K011467 · Ross Products
KNT · Tubes, Gastrointestinal (and Accessories) · 88d
Cleared Aug 10, 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL MANOMETRY APPLICATION, POLYGRAF ID
K011472 · Medtronic Functional Diagnostics A/S
FFX · System, Gastrointestinal Motility (electrical) · 88d
Cleared Aug 10, 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · Olympus Optical Co., Ltd.
FBK · Endoscopic Injection Needle, Gastroenterology-urology · 88d
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

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All categories 8431 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 146 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