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
Apr 10, 2013
PENTAX EPK-I5010 VIDEO PROCESSOR
PEA
Endoscope, Accessories, Image Post-processing For Color Enhancement
240d
Cleared
Apr 04, 2013
LIFE-CARE VAGINAL PROBE LIFE-CARE ANAL PROBE
KPI
Stimulator, Electrical, Non-implantable, For Incontinence
254d
Cleared
Apr 03, 2013
THE RICHARD WOLF ENDOCAM LOGIC HD CAMERA SYSTEM 5525
FET
Endoscopic Video Imaging System/component, Gastroenterology-urology
42d
Cleared
Apr 02, 2013
AMECATH DUAL LUMEN HEMODIALYSIS CATHETER
MSD
Catheter, Hemodialysis, Implanted
103d
Cleared
Mar 28, 2013
BOEHRINGER GASTRIC SIZING TUBE
KNT
Tubes, Gastrointestinal (and Accessories)
31d
Cleared
Mar 25, 2013
AQUABOSS ECORO DIA I (HT)
FIP
Subsystem, Water Purification
84d
Cleared
Mar 22, 2013
ENDOSCOPIC INTRODUCER
FED
Endoscopic Access Overtube, Gastroenterology-urology
175d
Cleared
Mar 20, 2013
E-Z CHEK BLOOD LEAK TEST STRIPS
FJD
Detector, Leak, Blood
99d
Cleared
Mar 14, 2013
NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (28CM) NEXSITE HD HEMODIALYSIS CATHETER FOR LONG TERM USE (24CM)
MSD
Catheter, Hemodialysis, Implanted
255d
Cleared
Mar 08, 2013
INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
MNW
Analyzer, Body Composition
144d
Cleared
Mar 07, 2013
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
122d
Cleared
Mar 06, 2013
INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE
FPD
Tube, Feeding
352d
Cleared
Mar 01, 2013
EVOLUTION BILIARY STENT SYSTEM
FGE
Stents, Drains And Dilators For The Biliary Ducts
291d
Cleared
Mar 01, 2013
CASSI II ROTATIONAL CORE BIOPSY SYSTEM
KNW
Instrument, Biopsy
100d
Cleared
Mar 01, 2013
RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
FED
Endoscopic Access Overtube, Gastroenterology-urology
91d
Cleared
Feb 28, 2013
LOFRIC SENSE
EZD
Catheter, Straight
84d
Cleared
Feb 26, 2013
OSTAVI HYDROPHILIC GUIDEWIRE
OCY
Endoscopic Guidewire, Gastroenterology-urology
57d
Cleared
Feb 19, 2013
DESARA SL
OTN
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
232d
Cleared
Feb 15, 2013
2008 HEMODIALYSIS SORBENT SYSTEM
FKT
System, Dialysate Delivery, Sorbent Regenerated
64d
Cleared
Feb 06, 2013
ASAHI REXEED-SX/LX SERIES DIALYZER
KDI
Dialyzer, High Permeability With Or Without Sealed Dialysate System
271d
Cleared
Feb 06, 2013
SHERPA PAK CARDIAC TRANSPORT SYSTEM
MSB
System And Accessories, Isolated Heart, Transport And Preservation
103d
Cleared
Feb 04, 2013
VARI-PASS VARIABLE LENGTH ACCESS SHEATH
KNY
Accessories, Catheter, G-u
118d
Cleared
Feb 04, 2013
AUTOMATED ENDOSCOPE LEAK TESTER
PCV
Endoscopic Leak Tester
63d
Cleared
Jan 31, 2013
PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH
MSD
Catheter, Hemodialysis, Implanted
112d
Cleared
Jan 25, 2013
POWER LED 175
FCW
Light Source, Fiberoptic, Routine
35d
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