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
8406 Gastroenterology & Urology devices
Cleared
Jul 10, 2009
WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS
FIP
Subsystem, Water Purification
207d
Cleared
Jul 10, 2009
COOK UROLOGICAL GRAFT
PAG
Mesh, Surgical, Non-synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
116d
Cleared
Jul 07, 2009
TANITA BODY COMPOSITION ANALYZER, MODEL SC-331
MNW
Analyzer, Body Composition
133d
Cleared
Jul 07, 2009
THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPE SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
20d
Cleared
Jul 02, 2009
DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R)
ODC
Endoscope Channel Accessory
94d
Cleared
Jul 01, 2009
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
ESW
Prosthesis, Esophageal
13d
Cleared
Jun 30, 2009
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518
FBK
Endoscopic Injection Needle, Gastroenterology-urology
50d
Cleared
Jun 29, 2009
NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER
FIP
Subsystem, Water Purification
90d
Cleared
Jun 29, 2009
HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L
NWB
Endoscope, Accessories, Narrow Band Spectrum
83d
Cleared
Jun 26, 2009
ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165
KGE
Forceps, Biopsy, Electric
114d
Cleared
Jun 26, 2009
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730
ESW
Prosthesis, Esophageal
35d
Cleared
Jun 25, 2009
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285
KNT
Tubes, Gastrointestinal (and Accessories)
195d
Cleared
Jun 17, 2009
COSTORSOL
KDN
System, Perfusion, Kidney
50d
Cleared
Jun 11, 2009
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES
FER
Anoscope And Accessories
22d
Cleared
Jun 10, 2009
HABIB ENDOHPB
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
212d
Cleared
Jun 09, 2009
PRECISION ENDOSCOPIC INFRARED COAGULATOR
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
215d
Cleared
Jun 09, 2009
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350
FPD
Tube, Feeding
34d
Cleared
Jun 05, 2009
EXALIS, SOFTWARE VERSION 1.15
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
224d
Cleared
Jun 04, 2009
REVOLUTION FULL CORE BIOPSY
KNW
Instrument, Biopsy
90d
Cleared
Jun 02, 2009
BACKSTOP AND BACKSTOP INJECTOR
ONJ
Dissolvable Gel For Preventing Ureteral Stone Migration
103d
Cleared
May 29, 2009
EXTT-101
HIR
Perineometer
277d
Cleared
May 29, 2009
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION
ODA
Endoscopic Central Control Unit
175d
Cleared
May 29, 2009
HEMORPEX SYSTEM
FER
Anoscope And Accessories
99d
Cleared
May 28, 2009
PERCUCATH URINARY CATHETER
EZL
Catheter, Retention Type, Balloon
114d
Cleared
May 28, 2009
DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
MSD
Catheter, Hemodialysis, Implanted
90d
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