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
2137–2160 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 27, 2013
NXSTAGE 1.6M2 DIALYZER
K131050 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 256d
Cleared Dec 23, 2013
CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER...
K132500 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 136d
Cleared Dec 20, 2013
ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER
K131935 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
IMAGE1 SPIES
K131953 · FET
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 176d
Cleared Dec 20, 2013
SEAL BIOPSY VALVE - REUSABLE
K132776 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 106d
Cleared Dec 20, 2013
NEOTRACT UROLIFT SYSTEM
K133281 · PEW
Neotract, Inc.
Gastroenterology & Urology · 56d
Cleared Dec 20, 2013
MULTI-STAGE SNARE
K133513 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 38d
Cleared Dec 19, 2013
PHYSOFT AMS
K130579 · MQS
Physicians Software Systems, LLC
Gastroenterology & Urology · 289d
Cleared Dec 19, 2013
ENTUIT THRIVE BALLOON RETENTION GASTROSTOMY FEEDING TUBE
K130611 · KNT
Xeridiem Medical Devices
Gastroenterology & Urology · 287d
Cleared Dec 19, 2013
ELISIO-H HEMODIALYZER
K131381 · KDI
Nipro Medical Corporation
Gastroenterology & Urology · 219d
Not Cleared Dec 18, 2013
AXIOS STENT AND DELIVERY SYSTEM
DEN130007 · PCU
Xlumena, Inc.
Gastroenterology & Urology · 302d
Cleared Dec 17, 2013
ERBEFLO CLEVERCAP HYBRID TUBING/CAP SET FOR PENTAX SCOPES, ERBEFLO CLEVERCAP...
K132340 · FEQ
Erbe USA, Inc.
Gastroenterology & Urology · 144d
Cleared Dec 16, 2013
CLEARGUARD HD END CAP
K131060 · PEH
Pursuit Vascular, Inc.
Gastroenterology & Urology · 244d
Cleared Dec 11, 2013
THD N-ANO ANOSCOPE
K133687 · FER
Thd Spa
Gastroenterology & Urology · 9d
Cleared Dec 06, 2013
ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
K130004 · ESW
Boston Scientific Corporation
Gastroenterology & Urology · 338d
Cleared Dec 06, 2013
SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA SYSTEM SOFTWARE, SPECTRA OPTIA...
K132429 · LKN
Terumobct, Inc.
Gastroenterology & Urology · 123d
Cleared Dec 05, 2013
SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS
K131229 · OTN
American Medical Systems
Gastroenterology & Urology · 219d
Cleared Dec 04, 2013
NIPRO PUREFLUX-L HEMODIALYZER
K122952 · FJI
Nipro Medical Corporation
Gastroenterology & Urology · 435d
Cleared Dec 04, 2013
MINS NEEDLESCOPIC RESPOSABLE DEVICE SYSTEM
K132232 · OCW
Minilap Technologies
Gastroenterology & Urology · 139d
Cleared Nov 26, 2013
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
K131369 · FGB
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 197d
Cleared Nov 26, 2013
CYBERWAND STERILE PROBE SET
K132795 · FFK
Cybersonics, Inc.
Gastroenterology & Urology · 81d
Cleared Nov 25, 2013
INBODY
K130777 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 249d
Cleared Nov 25, 2013
BIA / VITALITY ANALYZER
K130856 · MNW
Ipgdx, LLC
Gastroenterology & Urology · 242d
Cleared Nov 22, 2013
REDSENSE ALARM SYSTEM
K130554 · ODX
Redsense Medical AB
Gastroenterology & Urology · 263d