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
2476–2500 of 5372
Cleared Feb 11, 2002
SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K020052 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 34d
Cleared Feb 08, 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · Medical Components, Inc.
MSD · Catheter, Hemodialysis, Implanted · 184d
Cleared Feb 04, 2002
NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100
K013655 · Nxstage Medical, Inc.
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 90d
Cleared Jan 18, 2002
MODIFICATION TO DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM
K014184 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 29d
Cleared Jan 14, 2002
INCARE ADVANCE
K013483 · Hollister, Inc.
KOD · Catheter, Urological · 87d
Cleared Jan 11, 2002
NUTRISAFE PUR ENTERAL FEEDING TUBE
K003311 · Vygon Corp.
FPD · Tube, Feeding · 445d
Cleared Jan 07, 2002
INCARE INTERMITTENT CATHETER
K013345 · Hollister, Inc.
KOD · Catheter, Urological · 90d
Cleared Jan 07, 2002
DYNALINK .018 BILLARY SELF-EXPANDING STENT SYSTEM
K014007 · Guidant Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 33d
Cleared Dec 19, 2001
MICROGYN PLUS STIMULATION DEVICE
K013141 · Hollister, Inc.
KPI · Stimulator, Electrical, Non-implantable, For Incontinence · 90d
Cleared Dec 11, 2001
HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE
K013066 · Olympus America, Inc.
MND · Ligator, Esophageal · 90d
Cleared Dec 05, 2001
HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469
K012988 · Baxter Healthcare Corp
FKX · System, Peritoneal, Automatic Delivery · 90d
Cleared Nov 30, 2001
SERIM BLOOD LEAK TEST STRIP-2
K012115 · Serim Research Corp.
FJD · Detector, Leak, Blood · 147d
Cleared Nov 28, 2001
ULTRA-THIN SDS BALLOON DILATATION CATHETER
K011909 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 162d
Cleared Nov 20, 2001
CLIRANS E-SERIES DIALYZER
K013550 · Terumo Medical Corp.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 27d
Cleared Nov 16, 2001
FANELLI BILIARY STENT
K010601 · Cook, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 261d
Cleared Nov 16, 2001
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS
K011121 · Rusch Intl.
LJE · Catheter, Nephrostomy · 218d
Cleared Nov 16, 2001
HILL-ROM PRIMAVIEW MONITOR SYSTEM
K013709 · Hill-Rom, Inc.
FET · Endoscopic Video Imaging System/component, Gastroenterology-urology · 8d
Cleared Nov 15, 2001
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE
K012752 · Boston Scientific Corp
FGE · Stents, Drains And Dilators For The Biliary Ducts · 91d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · Omron Healthcare, Inc.
MNW · Analyzer, Body Composition · 162d
Cleared Nov 07, 2001
REPROCESSED ENDOSCOPIC TROCAR
K012578 · Sterilmed, Inc.
NLM · Laparoscope, General & Plastic Surgery, Reprocessed · 90d
Cleared Oct 26, 2001
SPARC SLING SYSTEM
K013355 · American Medical Systems, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 16d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX
K012822 · Boston Scientific Scimed, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820, 1821, 1825, 1826, 1830, 1831, 1835, 1836
K012864 · Boston Scientific Corp
FCG · Biopsy Needle · 58d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · Nxstage Medical, Inc.
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 74d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · C.R. Bard, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 29d

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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