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
8414 Gastroenterology & Urology devices
3001–3025 of 8414
Cleared Mar 19, 2008
MEDLINE GASTROSTOMY TUBE
K073718 · Medline Industries, Inc.
KGC · Tube, Gastro-enterostomy · 79d
Cleared Mar 18, 2008
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
K072301 · Ev3, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 214d
Cleared Mar 18, 2008
EVIS EXERA II 180 SYSTEM
K072957 · Olympus Medical Systems Corporation
NWB · Endoscope, Accessories, Narrow Band Spectrum · 151d
Cleared Mar 14, 2008
AMT INITIAL PLACEMENT GI KIT (E2418) AND AMT DILATOR SET (E2419)
K073034 · Applied Medical Technology, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 140d
Cleared Mar 10, 2008
ETHICON ENDO SURGERY SHEATH AND ARTICULATING ACCESSORY CHANNEL - GASTROSCOPE, MODEL IN0431
K073484 · Ethicon Endo-Surgery, Inc.
ODC · Endoscope Channel Accessory · 90d
Cleared Mar 06, 2008
SANARUS INCORE ROTATIONAL CORE BIOPSY DEVICE, MODELS CB3010, CB3012
K080171 · Sanarus Medical, Inc.
KNW · Instrument, Biopsy · 42d
Cleared Mar 05, 2008
ANCHORAGE ACCESS KIT
K073507 · Epitek, Inc.
ODC · Endoscope Channel Accessory · 83d
Cleared Mar 05, 2008
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
K073552 · Laborie Medical Technologies, Corp.
FEN · Device, Cystometric, Hydraulic · 78d
Cleared Mar 05, 2008
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG
K080340 · Novartis Nutrition Corp.
KNT · Tubes, Gastrointestinal (and Accessories) · 26d
Cleared Mar 03, 2008
MINITAPE EXTRA URETHRAL SLING
K073647 · Mpathy Medical Devices, Ltd.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 68d
Cleared Feb 27, 2008
WALLFLEX PARTIALLY COVERED ESOPHAGEAL STENT SYSTEM
K073266 · Boston Scientific Corp
ESW · Prosthesis, Esophageal · 99d
Cleared Feb 26, 2008
KIMBERLY-CLARK INTRODUCER KITS
K080253 · Kimberly-Clark Corp.
KGC · Tube, Gastro-enterostomy · 26d
Cleared Feb 25, 2008
MINITAPE URETHRAL SLING
K073646 · Mpathy Medical Devices, Ltd.
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 61d
Cleared Feb 21, 2008
AQUA PURE DEIONIZER EXCHANGE SERVICE
K072158 · Staubach Barror Water Systems, Inc.
FIP · Subsystem, Water Purification · 202d
Cleared Feb 21, 2008
NIPRO TRANSDUCER PROTECTOR TP-SURE, MODEL TPSURE+1
K072988 · Nipro Medical Corporation
FIB · Protector, Transducer, Dialysis · 121d
Cleared Feb 06, 2008
SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB
K062798 · Cordis Corp.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 505d
Cleared Feb 04, 2008
PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPY
K072908 · Gambro Renal Products
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 115d
Cleared Feb 01, 2008
PRISMAFLEX SYSTEM, VERSION 3.20
K072093 · Gambro
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 186d
Cleared Jan 31, 2008
SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120
K071646 · Idev Technologies, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 227d
Cleared Jan 30, 2008
PIEZOLITH 3000 TRIPLE-FOCUS LITHOTRIPTER
K072538 · United Medical Systems, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 145d
Cleared Jan 30, 2008
AMS MINIARC SLING SYSTEM
K073703 · American Medical Systems, Inc.
PAH · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling · 30d
Cleared Jan 29, 2008
SOLCART B
K072760 · B. Braun Medizintechnologie GmbH
KPO · Dialysate Concentrate For Hemodialysis (liquid Or Powder) · 123d
Cleared Jan 29, 2008
DECATHLON TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DE19SH24, DE23SH28, DE27SH32, DE31SH36, DE35SH40,
K073092 · Spire Biomedical, Inc.
MSD · Catheter, Hemodialysis, Implanted · 89d
Cleared Jan 24, 2008
SKATER BILIARY CATHETER
K073672 · Angiotech
FGE · Stents, Drains And Dilators For The Biliary Ducts · 28d
Cleared Jan 22, 2008
DECATHLON GOLD TWIN LUMEN HEMODIALYSIS CATHETER WITH SEPARATED TIPS, MODELS DEC19SH24, DEC23SH28, DEC23SH32, DEC31SH36,
K073093 · Spire Biomedical, Inc.
MSD · Catheter, Hemodialysis, Implanted · 82d

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All categories 8414 KNT Tubes, Gastrointestinal (and Accessories) 524 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 145 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 105 KNX Collector, Urine, (and Accessories) For Indwelling Catheter 104