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
1993–2016 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 23, 2014
Flexible Video-Uretero-Choledochoscope System
K142556 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 42d
Cleared Oct 21, 2014
JAGWIRE HIGH PERFORMANCE GUIDWIRE
K141820 · OCY
Boston Scientific Corp
Gastroenterology & Urology · 106d
Cleared Oct 17, 2014
EXPEL NEPHROURETERAL DRAINAGE STENT WITH TWIST-LOC HUB SYSTEM, EXPEL URETERAL...
K141344 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 148d
Cleared Oct 17, 2014
EXPEL APD DRAINAGE CATHETER SYSTEM
K141335 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 149d
Cleared Oct 17, 2014
CEDIC ENTERAL DISTAL END ENFIT TRANSITION CONNECTOR, CEDIC ENTERAL ENFIT...
K140581 · PIO
Cedic S.R.L.
Gastroenterology & Urology · 225d
Cleared Oct 16, 2014
AQUARIUS NASAL FEEDING TUBE
K141753 · PIF
Degania Silicone , Ltd.
Gastroenterology & Urology · 108d
Not Cleared Oct 14, 2014
INFLOW INTRAURETHRAL VALVE-PUMP
DEN130044 · PIH
Vesiflo, Inc.
Gastroenterology & Urology · 354d
Cleared Oct 10, 2014
OSTOM-I ALERT
K140938 · EXB
11 Health and Technologies, LLC
Gastroenterology & Urology · 182d
Cleared Oct 10, 2014
HS NOTA
K131925 · FCG
H.S. Hospital Services S.P.A.
Gastroenterology & Urology · 471d
Cleared Oct 09, 2014
IEVA REHABILITATIVE POSITIONAL DEVICE
K133990 · HIR
Remendium Labs, LLC
Gastroenterology & Urology · 286d
Cleared Oct 06, 2014
SHARKCORE FINE NEEDLE BIOPSY SYSTEM
K141894 · FCG
Covidien, LLC( Formerly Beacon...
Gastroenterology & Urology · 84d
Cleared Sep 30, 2014
PolyCatch Retrieval Device
K142258 · FDI
Medi-Globe Corporation
Gastroenterology & Urology · 47d
Cleared Sep 30, 2014
ESOPHYX2 HD
K142113 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Sep 30, 2014
FUSE COLONOSCOPY SYSTEM
K141598 · FDF
Endochoice, Inc.
Gastroenterology & Urology · 109d
Cleared Sep 30, 2014
AER-O-SCOPE COLONOSCOPE SYSTEM
K141286 · FDF
Gi View , Ltd.
Gastroenterology & Urology · 137d
Cleared Sep 26, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
K131817 · LNS
Osmunda Medical Device Consulting...
Gastroenterology & Urology · 463d
Cleared Sep 25, 2014
ESOFLIP ES
K142000 · PIE
Crospon, Ltd.
Gastroenterology & Urology · 64d
Cleared Sep 24, 2014
POWER-TRIALYSIS SHORT-TERM DIALYSIS CATHETER
K133456 · NIE
C.R. Bard, Inc.
Gastroenterology & Urology · 316d
Cleared Sep 23, 2014
BIOSPACE BODY COMPOSITION ANALYZER
K141483 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 110d
Cleared Sep 19, 2014
Predicate III Guidewire
K142397 · OCY
Lake Region Medical
Gastroenterology & Urology · 23d
Cleared Sep 11, 2014
RANFAC ASPIRATION NEEDLE WITH ADJUSTABLE GUIDE
K140991 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 147d
Cleared Sep 11, 2014
TABLO CARTRIDGE
K140841 · FJK
Home Dialysis Plus
Gastroenterology & Urology · 162d
Cleared Sep 11, 2014
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE...
K134019 · FIE
Nxstage Medical, Inc.
Gastroenterology & Urology · 255d
Cleared Sep 10, 2014
TABLO CONSOLE
K140866 · KDI
Home Dialysis Plus
Gastroenterology & Urology · 160d