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
8390 Gastroenterology & Urology devices
Cleared
May 20, 2013
MIROCAM CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
194d
Cleared
May 17, 2013
SCOPEVALET DISPOSABLE BIOPSY VALVE
OCX
Endoscopic Irrigation/suction System
282d
Cleared
May 16, 2013
GATEWAY ADVANAGE Y-ADAPTER
OCX
Endoscopic Irrigation/suction System
45d
Cleared
May 14, 2013
HYDROSIL
EZD
Catheter, Straight
245d
Cleared
May 14, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
LNS
Lithotriptor, Extracorporeal Shock-wave, Urological
57d
Cleared
May 13, 2013
REMINGTON MEDICAL CENTREFIRE 22 BIOPSY INSTRUMENT
KNW
Instrument, Biopsy
97d
Cleared
May 10, 2013
NEXTSTEP RETROGRADE
MSD
Catheter, Hemodialysis, Implanted
105d
Cleared
May 09, 2013
TEMPERATURE SENSOR CATHETER
EZL
Catheter, Retention Type, Balloon
27d
Cleared
May 07, 2013
PUREFLUX-H HEMODIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
277d
Cleared
May 07, 2013
PROTEUS PATCH, INGESTIBLE SENSOR (ACCESSORY)
OZW
Ingestible Event Marker
26d
Cleared
May 02, 2013
SECA MEDICAL BODY COMPOSTION ANALYZER 514, SECA MBCA 514, SECA MBCA, SECA 514
MNW
Analyzer, Body Composition
269d
Cleared
May 02, 2013
REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
115d
Cleared
May 02, 2013
SUPERA VERITAS
FGE
Stents, Drains And Dilators For The Biliary Ducts
56d
Cleared
May 01, 2013
ELISIO-H AND ELISIO-M HEMODIALYZERS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
271d
Cleared
Apr 29, 2013
OLYMPUS SMALL INTESTINAL CAPSULE ENDOSCOPE SYSTEM
NEZ
System, Imaging, Gastrointestinal, Wireless, Capsule
174d
Cleared
Apr 29, 2013
SINGLE USE REPOSITIONABLE CLIP
PKL
Hemostatic Metal Clip For The Gi Tract
159d
Cleared
Apr 25, 2013
DEONIZATION EXCHANGE TANKS, CARBON EXCHANGE TANKS
FIP
Subsystem, Water Purification
185d
Cleared
Apr 23, 2013
NXSTAGE SYSTEM ONE
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
285d
Cleared
Apr 19, 2013
AMT LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE KIT
KNT
Tubes, Gastrointestinal (and Accessories)
136d
Cleared
Apr 19, 2013
FALLER STYLET
FJS
Catheter, Peritoneal, Long-term Indwelling
57d
Cleared
Apr 19, 2013
ELECTRODE, FLEXIBLE SUCTION COAGULATOR
FEH
Electrode, Flexible Suction Coagulator
53d
Cleared
Apr 18, 2013
COMINED STANDARD SOLUTION
FKH
Solution-test Standard-conductivity, Dialysis
93d
Cleared
Apr 17, 2013
INSTAFLO BOWEL CATHETER SYSTEM KIT
KNT
Tubes, Gastrointestinal (and Accessories)
128d
Cleared
Apr 16, 2013
PEERSCOPE SYSTEM
FDF
Colonoscope And Accessories, Flexible/rigid
29d
Cleared
Apr 11, 2013
SINGLE USE PRELOADED SPHINCTEROTOME V
KNS
Unit, Electrosurgical, Endoscopic (with Or Without Accessories)
238d
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