FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Gastroenterology & Urology ×
9,870 results
3241–3264 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 06, 2006
RX HERCULINK ELITE BILIARY STENT SYSTEM
K053454 · FGE
Guidant Corporation
Gastroenterology & Urology · 87d
Cleared Mar 01, 2006
INTEGRA
K053640 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 61d
Cleared Feb 28, 2006
NIPRO HYDROPHILIC GUIDEWIRE FOR UROLOGICAL & LAPAROSCOPIC USE
K060034 · OCY
Nipro Medical Corporation
Gastroenterology & Urology · 54d
Cleared Feb 24, 2006
PEDIATRIC URINARY CATHETER
K060268 · GBM
Clay Kennard
Gastroenterology & Urology · 23d
Cleared Feb 16, 2006
MEDLINE SILVERTOUCH 100% SILICONE FOLEY CATHETER, MODEL MEDLINE INDUSTRIES, INC.
K052168 · EZL
Medline Industries, Inc.
Gastroenterology & Urology · 191d
Cleared Feb 16, 2006
HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS...
K053512 · FKX
Baxter Healthcare Corp
Gastroenterology & Urology · 62d
Cleared Feb 08, 2006
ADVANCED UROLOGICAL CATHETER
K053429 · EZL
Entracare, LLC
Gastroenterology & Urology · 61d
Cleared Feb 03, 2006
T-SLING
K050516 · OTN
Herniamesh S.R.L.
Gastroenterology & Urology · 339d
Cleared Feb 03, 2006
AMS MALE TRANSOBTURATOR SLING SYSTEM
K053371 · OTM
American Medical Systems, Inc.
Gastroenterology & Urology · 60d
Cleared Feb 02, 2006
AQUADEX FLEXFLOW SYSTEM
K060008 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 30d
Cleared Jan 31, 2006
HPH JUNIOR HIGH PERFORMANCE HEMOCONCENTRATOR
K050952 · KDI
Minntech Corp.
Gastroenterology & Urology · 291d
Cleared Jan 31, 2006
NAVIGATOR ENDOSCOPY SYSTEM
K052930 · FDF
Neoguide Systems, Inc.
Gastroenterology & Urology · 104d
Cleared Jan 31, 2006
TECHDEVICE GUIDEWIRE
K053028 · OCY
Techdevice Corporation
Gastroenterology & Urology · 96d
Cleared Jan 17, 2006
RM3 RENAL PRESERVATION SYSTEM
K053169 · KDK
Waters Instruments, Inc.
Gastroenterology & Urology · 64d
Cleared Jan 06, 2006
AMERIWATER SOLUTION MIX AND DISTRIBUTION SYSTEM FOR HEMODIALYSIS
K051031 · FIN
Ameriwater
Gastroenterology & Urology · 259d
Cleared Jan 06, 2006
MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
K053322 · FAS
Roei Medical Technologies, Ltd.
Gastroenterology & Urology · 37d
Cleared Jan 06, 2006
GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR
K053410 · FEG
Kendall
Gastroenterology & Urology · 30d
Cleared Dec 27, 2005
AQ-830 SLIM BODY, BODY FAT MONITOR
K052678 · MNW
Limax Electronics Co., Ltd.
Gastroenterology & Urology · 90d
Cleared Dec 27, 2005
E-Z-EM ENDOSCOPIC CO2 REGULATOR
K053008 · FCX
E-Z-Em, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 22, 2005
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
K053286 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 27d
Cleared Dec 21, 2005
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
K053404 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 14d
Cleared Dec 20, 2005
CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
K052135 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 137d
Cleared Dec 20, 2005
GP GENERAL PURPOSE DRAINAGE CATHETER
K053245 · FGE
Uresil, LLC
Gastroenterology & Urology · 29d
Cleared Dec 16, 2005
BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20
K052646 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 81d