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
8396 Gastroenterology & Urology devices
2501–2525 of 8396
Cleared Nov 03, 2011
BRACCO DIAGNOSTICS, INC. CO2MPACT ENDODCOPIC INSUFFLATOR
K111648 · Bracco Diagnostic, Inc.
FCX · Insufflator, Automatic Carbon-dioxide For Endoscope · 143d
Cleared Nov 03, 2011
ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM
K112945 · Inrad, Inc.
KNW · Instrument, Biopsy · 30d
Cleared Nov 01, 2011
TRANSTEK
K112932 · Zhongshan Transtek Electronics Co., Ltd.
MNW · Analyzer, Body Composition · 29d
Cleared Nov 01, 2011
BODY ANALYSIS SCALE
K112951 · Shenzhen Healthcare Electronic Technology Co., Ltd.
MNW · Analyzer, Body Composition · 28d
Cleared Oct 28, 2011
SUMO ACCESS AND TISSUE RESECTION SYSTEM
K103155 · Apollo Endosurgery, Inc.
ODC · Endoscope Channel Accessory · 367d
Cleared Oct 27, 2011
JMS APHERESIS NEEDLE SET WINGEATER(R) V2
K112178 · JMS North America Corporation
FIE · Needle, Fistula · 91d
Cleared Oct 25, 2011
CHARGER BALLOON DILATATION CATHETER
K112701 · Boston Scientific
FGE · Stents, Drains And Dilators For The Biliary Ducts · 39d
Cleared Oct 24, 2011
WINGEATER V2
K111948 · JMS North America Corporation
FIE · Needle, Fistula · 108d
Cleared Oct 21, 2011
FRESENIUS 2008T HEMODIALYSIS MACHINE
K111639 · Fresenius Medical Care
KDI · Dialyzer, High Permeability With Or Without Sealed Dialysate System · 130d
Cleared Oct 20, 2011
THE ONCONTROL BONE ACCESS SYSTEM BY VIDACARE
K112468 · Regulatory Specialists, Inc.
KNW · Instrument, Biopsy · 55d
Cleared Oct 19, 2011
AMT G-J TUBE
K110804 · Applied Medical Technology, Inc.
KNT · Tubes, Gastrointestinal (and Accessories) · 211d
Cleared Oct 19, 2011
SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS
K111766 · Idev Technologies, Inc.
FGE · Stents, Drains And Dilators For The Biliary Ducts · 118d
Cleared Oct 13, 2011
NUTRISAFE 2 FEEDING TUBES MODEL 362.XXX. 1362.XXX
K100163 · Vygon Corp.
FPD · Tube, Feeding · 631d
Cleared Oct 07, 2011
HUIBAO BODY FAT SCALE
K111404 · Zhongshan Huibao Weighing Apparatus Co., Ltd.
MNW · Analyzer, Body Composition · 141d
Cleared Oct 06, 2011
ENDOFLIP ECD
K110531 · Crospon, Ltd.
FED · Endoscopic Access Overtube, Gastroenterology-urology · 224d
Cleared Oct 05, 2011
AMERIWATER MRO PORTABLE REVERSE OSMOSIS SYSTEM - SINGLE PATIENT, 1 TO 3 STATION
K111740 · Ameriwater
FIP · Subsystem, Water Purification · 106d
Cleared Sep 30, 2011
DESARA MESH
K112609 · Caldera Medical, Inc.
OTN · Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator · 22d
Cleared Sep 29, 2011
BD ORAL/ENTERAL SYRINGE WITH BD UNIVIA CONNECTION
K112434 · Bd Medical Surgical
KNT · Tubes, Gastrointestinal (and Accessories) · 36d
Cleared Sep 28, 2011
LITE-MED LM-9200 ELMA
K103217 · Lite-Med, Inc.
LNS · Lithotriptor, Extracorporeal Shock-wave, Urological · 331d
Cleared Sep 28, 2011
PALINDROME H, SI, HSI CHRONIC CATHETER
K112477 · Covidien
NYU · Catheter, Hemodialysis, Implanted, Coated · 30d
Cleared Sep 19, 2011
NXSTAGE PUREFLOW SL
K111174 · Nxstage Medical, Inc.
FKR · Subsystem, Proportioning · 145d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · Boston Scientific Corporation
ODG · Endoscopic Ultrasound System, Gastroenterology-urology · 44d
Cleared Sep 09, 2011
UNIMAX ANTI-FOG SOLUTION
K111622 · Unimax Medical Systems, Inc.
OCT · Anti Fog Solution And Accessories, Endoscopy · 91d
Cleared Sep 08, 2011
PREFILLED CATHETER INFLATION SYRINGE
K112209 · Avail Medical Products, Inc.
KNY · Accessories, Catheter, G-u · 38d
Cleared Sep 06, 2011
FULL CORE BIOPSY SYSTEM
K111765 · Promex Technologies, LLC
KNW · Instrument, Biopsy · 75d

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All categories 8396 KNT Tubes, Gastrointestinal (and Accessories) 524 FGE Stents, Drains And Dilators For The Biliary Ducts 460 KDI Dialyzer, High Permeability With Or Without Sealed Dialysate System 330 KNW Instrument, Biopsy 279 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