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
8420 Gastroenterology & Urology devices
Cleared
Jan 17, 2006
RM3 RENAL PRESERVATION SYSTEM
KDK
Container, Transport, Kidney
64d
Cleared
Jan 06, 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
FIN
Tank, Holding, Dialysis
259d
Cleared
Jan 06, 2006
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
FAS
Electrode, Electrosurgical, Active, Urological
37d
Cleared
Jan 06, 2006
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
FEG
Tube, Double Lumen For Intestinal Decompression And/or Intubation
30d
Cleared
Dec 27, 2005
AQ-830 SLIM BODY, BODY FAT MONITOR
MNW
Analyzer, Body Composition
90d
Cleared
Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
FCX
Insufflator, Automatic Carbon-dioxide For Endoscope
62d
Cleared
Dec 22, 2005
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
KPO
Dialysate Concentrate For Hemodialysis (liquid Or Powder)
27d
Cleared
Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
14d
Cleared
Dec 20, 2005
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
FFK
Lithotriptor, Electro-hydraulic
137d
Cleared
Dec 20, 2005
GP GENERAL PURPOSE DRAINAGE CATHETER
FGE
Stents, Drains And Dilators For The Biliary Ducts
29d
Cleared
Dec 16, 2005
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
MNW
Analyzer, Body Composition
81d
Cleared
Dec 15, 2005
SOLAR GI
FFX
System, Gastrointestinal Motility (electrical)
111d
Cleared
Dec 15, 2005
MENTOR ARIS SUPRAPUBIC SURGICAL KIT
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
20d
Cleared
Dec 13, 2005
STAYHEALTHY BODY COMPOSITION ANALYZER, MODELS BC1 AND BC2
MNW
Analyzer, Body Composition
90d
Cleared
Dec 09, 2005
GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
184d
Cleared
Dec 09, 2005
COOK FORMULA 418 BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
85d
Cleared
Dec 05, 2005
SKYLARK URO PROBE
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
40d
Cleared
Dec 01, 2005
GIVEN DIAGNOSTIC SYSTEM
NSI
System, Imaging, Esophageal, Wireless, Capsule
112d
Cleared
Nov 30, 2005
MEDCOMP SPLIT CATH II
MSD
Catheter, Hemodialysis, Implanted
197d
Cleared
Nov 28, 2005
GYNECARE TVT SECUR SYSTEM
PAH
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-sling
88d
Cleared
Nov 18, 2005
MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES
FIP
Subsystem, Water Purification
154d
Cleared
Nov 18, 2005
RUBICOR MAGIC BREAST BIOPSY DEVICE
KNW
Instrument, Biopsy
8d
Cleared
Nov 17, 2005
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
76d
Cleared
Nov 15, 2005
PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS
PNG
Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
141d
Cleared
Nov 14, 2005
OLYMPUS CHOLEDOCHOSCOPE, MODEL XCHF-BP160F
FBN
Choledochoscope And Accessories, Flexible/rigid
125d
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