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
1825–1848 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 03, 2015
Disposable Endoscope Valves Set A
K151714 · ODC
Wilson Instruments (Shanghai) Company...
Gastroenterology & Urology · 161d
Cleared Nov 24, 2015
OES ELITE Telescopes, Protective Tube
K151191 · FBP
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 204d
Cleared Nov 24, 2015
PENTAX Medical EPK-i7010 Video Processor with GI Family
K150618 · PEA
Pentax of America, Inc.
Gastroenterology & Urology · 259d
Cleared Nov 24, 2015
SilverCoat Silicone Foley Catheter
K150550 · EZL
Covalontechnologies, Inc.
Gastroenterology & Urology · 266d
Cleared Nov 20, 2015
WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis...
K152853 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 52d
Cleared Nov 20, 2015
Single Use Aspiration Needle NA-U200H
K151738 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 147d
Not Cleared Nov 20, 2015
RELIZORB
DEN150001 · PLQ
Alcresta, Inc.
Gastroenterology & Urology · 322d
Cleared Nov 19, 2015
MoisturemeterD
K143310 · OBH
Delfin Technologies, Ltd.
Gastroenterology & Urology · 366d
Cleared Nov 13, 2015
LithoVue System
K153049 · FGB
Boston Scientific Corporation
Gastroenterology & Urology · 24d
Cleared Nov 12, 2015
Eclipse System
K150558 · PJH
Pelvalon, Inc.
Gastroenterology & Urology · 253d
Cleared Nov 06, 2015
Ablatherm Integrated Imaging
K153023 · PLP
Edap Technomed, Inc.
Gastroenterology & Urology · 22d
Cleared Nov 06, 2015
Elation Wireguided Balloon Dilation Catheter
K151925 · FGE
Merit Medical Systems, Inc.
Gastroenterology & Urology · 116d
Cleared Nov 05, 2015
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K152953 · KOC
Fresenius Medical Care North America
Gastroenterology & Urology · 29d
Cleared Nov 03, 2015
rescuenet
K152580 · FDI
Endochoice, Inc.
Gastroenterology & Urology · 54d
Cleared Oct 29, 2015
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER...
K152675 · KDJ
Baxter Healthcare
Gastroenterology & Urology · 41d
Cleared Oct 29, 2015
Optiflux dialyzer
K152367 · KDI
Fresenius Medical Care North America
Gastroenterology & Urology · 69d
Cleared Oct 29, 2015
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with...
K152129 · KDJ
Baxter Healthcare Corporation
Gastroenterology & Urology · 90d
Cleared Oct 27, 2015
Express SD Biliary Monorail Premounted Stent System
K152607 · FGE
Boston Scientific
Gastroenterology & Urology · 46d
Cleared Oct 26, 2015
Resection Electrodes
K152092 · FAS
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 90d
Cleared Oct 23, 2015
Avitus Bone Harvester
K152474 · KNW
Avitus Orthopaedics, Inc.
Gastroenterology & Urology · 53d
Cleared Oct 22, 2015
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
K151895 · FCG
Boston Scientific Corporation
Gastroenterology & Urology · 104d
Cleared Oct 19, 2015
AquaC UNO H
K143617 · FIP
Vivonic GmbH
Gastroenterology & Urology · 304d
Cleared Oct 16, 2015
Disposable Multistage Dilation Balloon Catheter
K151671 · FGE
Micro-Tech (Nanjing) Co., Ltd.
Gastroenterology & Urology · 116d
Cleared Oct 15, 2015
iSnare system-Lariat
K152035 · FBK
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 85d