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
5373 Gastroenterology & Urology devices
2551–2575 of 5373
Cleared Mar 08, 2001
PERFADEX SOLUTION FOR ORGAN PRESERVATION
K000881 · Vitrolife Sweden AB
MSB · System And Accessories, Isolated Heart, Transport And Preservation · 353d
Cleared Mar 05, 2001
MENTOR SELF-CATH PLUS
K003784 · Mentor Corp.
EZL · Catheter, Retention Type, Balloon · 88d
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 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · Rusch Intl.
ESW · Prosthesis, Esophageal · 31d
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 18, 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · Ethicon Endo-Surgery, Inc.
KNW · Instrument, Biopsy · 90d
Cleared Jan 17, 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 271d
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
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · C.R. Bard, Inc.
EZL · Catheter, Retention Type, Balloon · 77d
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
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · C.R. Bard, Inc.
ODE · Endoscopic Suture/plication System, Gastroesophageal Reflux Disease (gerd) · 15d
Cleared Jan 04, 2001
FRESENIUS OPTIFLUX 200A
K003498 · Fresenius Medical Care North America
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 52d
Cleared Jan 04, 2001
GP GENERAL PURPOSE DRAINAGE SET, MINI-PIGTAIL DRAINAGE CATHETER WITH LOCKING PIGTAIL, GP GENERAL PURPOSE DRAINAGE CATHE
K003753 · Uresil Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 30d
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 Dec 05, 2000
NIPRO BLOOD TUBING SET FOR HEMODIALYSIS WITH TRANSDUCER PROTECTORS AND PRIMING SET
K001465 · Nipro Medical Corp.
FIB · Protector, Transducer, Dialysis · 209d
Cleared Dec 04, 2000
FRESNIUS HEMOFLOW F7NR, F50NR, F70NR HEMODIALYZERS
K002761 · Fresenius Medical Care North America
FJI · Dialyzer, Capillary, Hollow Fiber · 90d
Cleared Dec 01, 2000
FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2
K003445 · Fresenius Medical Care North America
FIB · Protector, Transducer, Dialysis · 25d
Cleared Nov 22, 2000
MODIFICATION TO S.M.A.R.T NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K003336 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
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
Cleared Nov 22, 2000
JAMSHIDI MARROW ACQUISITION CRADLE
K003370 · Allegiance Healthcare Corp.
KNW · Instrument, Biopsy · 23d
Cleared Nov 21, 2000
NIPRO SAFETOUCH SAFETY FISTULA NEEDLE
K002813 · Nipro Medical Corp.
FIE · Needle, Fistula · 74d

Looking for a specific gastroenterology & urology device? Search by device name, K-number or manufacturer.

Search all Gastroenterology & Urology 510(k) devices

Filter by Product Code

All categories 5373 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 130 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