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

9843
Total
9796
Cleared
154d
Avg (2y)
1976
Since
2625 Gastroenterology & Urology devices
1851–1875 of 2625
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
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
K012087 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jul 13, 2001
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp
KOD · Catheter, Urological · 18d
Cleared Jun 22, 2001
CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000
K011015 · C.R. Bard, Inc.
NFK · Kit, Repair, Catheter, Hemodialysis · 79d
Cleared May 09, 2001
INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
K011065 · Richard Wolf Medical Instruments Corp.
FFK · Lithotriptor, Electro-hydraulic · 30d
Cleared Apr 30, 2001
ALIEN RX MICRO CANNULA, MODEL 4530
K010993 · Boston Scientific Corp
ODD · Endoscopic Retrograde Cholangiopancreatography (ercp) Cannula · 27d
Cleared Apr 13, 2001
NIAGARA SLIM-CATH
K010778 · C.R. Bard, Inc.
MPB · Catheter, Hemodialysis, Non-implanted · 29d
Cleared Mar 28, 2001
OPTIFLOW CATHETER #5641190 CATHETER ONLY #5643150 CATHETER KIT #5631000 CATHETERLESS TRAY-GENERIC (COMBINED WITH CATHETR
K010567 · C.R. Bard, Inc.
MSD · Catheter, Hemodialysis, Implanted · 30d
Cleared Mar 27, 2001
RAPID EXCHANGE BIOPSY CAP AND LOCKING DEVICE #4526 & 4527
K010610 · Boston Scientific Corp
ODC · Endoscope Channel Accessory · 26d
Cleared Mar 27, 2001
KSEA SCB-RUI SCO
K003113 · KARL STORZ Endoscopy-America, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 174d
Cleared Mar 22, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K003929 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 92d
Cleared Mar 16, 2001
PRECISE NITINOL STENT TRANSHEPATIC BILLARY SYSTEM
K010445 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
Cleared Feb 27, 2001
OLYMPUS ENDOSCOPIC LIGATION DEVICE
K001744 · Olympus America, Inc.
MND · Ligator, Esophageal · 264d
Cleared Feb 14, 2001
SYNTRA DIALYZER, MODEL SYNTRA 120, 160
K002210 · Baxter Healthcare Corp
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 208d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · Smith & Nephew, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 63d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · Terumo Medical Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 90d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · Boston Scientific Corp
FAD · Stent, Ureteral · 20d
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 90d
Cleared Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · C.R. Bard, Inc.
ODE · Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) · 15d
Cleared Jan 05, 2001
BARD LUMINEXX BILIARY STENT
K003793 · C.R. Bard, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
Cleared Jan 05, 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 77d
Cleared Dec 11, 2000
MERIT DRAINAGE DEPOT
K003078 · Merit Medical Systems, Inc.
EXF · Bag, Bile Collecting · 69d
Cleared Dec 08, 2000
BARD ALL-SILICONE 3-WAY FOLEY CATHETER
K002868 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 86d
Cleared Nov 22, 2000
S.M.A.R.T NITINOL STENT ENDOSOPIC BILLARY SYSTEM (VARIOUS)
K003365 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 26d

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All categories 2625 FGE Stents, Drains And Dilators For The Biliary Ducts 186 KNT Tubes, Gastrointestinal (and Accessories) 125 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 78 FGB Ureteroscope And Accessories, Flexible/rigid 74 KNS Unit, Electrosurgical, Endoscopic (with Or Without Accessories) 70 PKL Hemostatic Metal Clip For The Gi Tract 50 FED Endoscopic Access Overtube, Gastroenterology-urology 48 FAD Stent, Ureteral 47 ODC Endoscope Channel Accessory 47 FAJ Cystoscope And Accessories, Flexible/rigid 47 KNW Instrument, Biopsy 44 OCX Endoscopic Irrigation/suction System 44 EZD Catheter, Straight 43 EZL Catheter, Retention Type, Balloon 43 FDS Gastroscope And Accessories, Flexible/rigid 41