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
4225–4248 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Feb 13, 2001
TUNA (TRANS URETHRA NEEDLE) OFFICE SYSTEM
K002583 · KNS
Vidamed, Inc.
Gastroenterology & Urology · 179d
Cleared Feb 13, 2001
MODULITH LITHOTRIPSY, MODEL SLK FOR THE FRAGMENTATION OF URINARY AND UPPER...
K010340 · LNS
Karl Storz Lithotripsy-America, Inc.
Gastroenterology & Urology · 8d
Cleared Feb 12, 2001
SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS
K003529 · LNS
Edap Technomed, Inc.
Gastroenterology & Urology · 88d
Cleared Feb 08, 2001
RUSCH POLYFLEX STENT FOR THE ESOPHAGUS WITH INTRODUCER SYSTEM
K010068 · ESW
Rusch Intl.
Gastroenterology & Urology · 31d
Cleared Feb 07, 2001
POLYGRAM 98 ESOPHAGEAL MANOMETRY TESTING APPLICATION, MODEL 9043S0103
K010130 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 22d
Cleared Feb 02, 2001
DYONICS VISION 337 AUTOCLAVABLE CAMERA HEAD MODEL 7209048
K003710 · FET
Smith & Nephew, Inc.
Gastroenterology & Urology · 63d
Cleared Feb 01, 2001
CLIRANS E-SERIES HOLLOW FIBER DIALYZERS
K003425 · KDI
Terumo Medical Corp.
Gastroenterology & Urology · 90d
Cleared Feb 01, 2001
SUCTION IRRIGATOR
K003443 · FHF
Applied Medical
Gastroenterology & Urology · 87d
Cleared Feb 01, 2001
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
K003615 · FKP
Environmental Test Systems, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 01, 2001
MODIFICATION TO CAVERMAP SURGICAL AID
K010098 · FGM
Uromed Corp.
Gastroenterology & Urology · 21d
Cleared Jan 30, 2001
LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES AND ANCILLARY...
K002231 · FDS
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 190d
Cleared Jan 24, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K003997 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 29d
Cleared Jan 23, 2001
HORIZONS ERCP CANNULA
K002235 · FGE
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Jan 23, 2001
HORIZONS PAPILLOTOME
K002236 · KNS
Horizons Intl. Corp.
Gastroenterology & Urology · 183d
Cleared Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
K002011 · MSY
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 203d
Cleared Jan 22, 2001
CONTOUR POLARIS URETERAL STENT
K010002 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 20d
Cleared Jan 18, 2001
MAMMOTOME HAND HELD PROBE, MODEL MHH8
K003297 · KNW
Ethicon Endo-Surgery, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 17, 2001
LIFEMATE HEMOFILTRATION SYSTEM
K001283 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 271d
Cleared Jan 11, 2001
PENILE CONSTRICTOR RING
K001859 · LKY
Basic Solutions, LLC
Gastroenterology & Urology · 206d
Cleared Jan 09, 2001
BARD MEMOTHERM ENDOSCOPIC BILIARY STENT
K003186 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 90d
Cleared Jan 05, 2001
BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED)
K003289 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 77d
Cleared Jan 05, 2001
BARD LUMINEXX BILIARY STENT
K003793 · FGE
C.R. Bard, Inc.
Gastroenterology & Urology · 28d
Cleared Jan 05, 2001
BARD ENDOCINCH SUTURING SYSTEM # 000452
K003956 · ODE
C.R. Bard, Inc.
Gastroenterology & Urology · 15d
Cleared Jan 04, 2001
FRESENIUS OPTIFLUX 200A
K003498 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 52d