FDA 510(k) Searchable Database - Search 176,325+ Clearances

Search 176,325+ 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.

176,325 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Gastroenterology & Urology ×
9,917 results
1801–1824 of 9,917
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared May 06, 2016
Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
K160740 · NLM
Surgical Instrument Service and...
Gastroenterology & Urology · 50d
Cleared May 06, 2016
Qora AIM Stool Management Kit, Qora Aeon Stool Management Kit, Qora Arida...
K153506 · KNT
Consure Medical Pvt , Ltd.
Gastroenterology & Urology · 151d
Cleared May 04, 2016
Soehendra Stent Retriever
K161203 · FGE
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 6d
Cleared May 04, 2016
Yarlap II
K160773 · KPI
International Trade Group, Inc.
Gastroenterology & Urology · 44d
Cleared May 04, 2016
GastriSail Gastric Positioning System 40 Fr/CH (13.3mm)
K160654 · KNT
Covidien, LLC
Gastroenterology & Urology · 57d
Cleared May 03, 2016
Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
K160845 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 36d
Cleared May 01, 2016
EsophyX® Z Device with SerosaFuse Fasteners and Accessories
K160960 · ODE
Endogastric Solutions, Inc.
Gastroenterology & Urology · 26d
Cleared May 01, 2016
EndoFLIP
K160725 · FFX
Crospon, Ltd.
Gastroenterology & Urology · 46d
Cleared Apr 28, 2016
ManoScan System
K151086 · FFX
Given Imaging , Ltd.
Gastroenterology & Urology · 372d
Cleared Apr 26, 2016
CompactCath Intermittent Urinary Catheter
K160858 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 28d
Cleared Apr 26, 2016
2008K2 Hemodialysis Machine
K153449 · KDI
Fresenius Medical Care Renal...
Gastroenterology & Urology · 148d
Cleared Apr 19, 2016
LumenR Tissue Retractor System
K153698 · ODB
Lumenr, LLC
Gastroenterology & Urology · 118d
Cleared Apr 15, 2016
CRIT-LINE III Blood Chamber II
K160749 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 28d
Cleared Apr 15, 2016
Accuryn Monitoring System
K153655 · EZL
Potrero Medical, Inc.
Gastroenterology & Urology · 116d
Cleared Apr 08, 2016
Nephros S100
K153084 · NHV
Nephros, Inc.
Gastroenterology & Urology · 165d
Cleared Apr 05, 2016
Medline ReNewal Reprocessed Versaport V2 Bladeless Optical Trocars
K153258 · NLM
Surgical Instrument Service and...
Gastroenterology & Urology · 147d
Cleared Apr 05, 2016
NUTRICARE-ISOSAF NASO-GASTRIC FEEDING TUBE
K151503 · PIF
Gbuk Enteral Limited
Gastroenterology & Urology · 306d
Cleared Apr 04, 2016
Centros Long-Term Hemodialysis Catheter, CentrosFLO Long-Term Hemodialysis...
K151967 · MSD
Merit Medical Systems, Inc.
Gastroenterology & Urology · 263d
Cleared Mar 31, 2016
Proxis Ureteral Access Sheath
K160861 · FED
C.R. Bard, Inc.
Gastroenterology & Urology · 2d
Cleared Mar 30, 2016
Rotatable Snares
K160637 · FDI
Boston Scientific Corporation
Gastroenterology & Urology · 23d
Cleared Mar 29, 2016
Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set
K152105 · PNG
Rocket Medical Plc
Gastroenterology & Urology · 244d
Cleared Mar 25, 2016
Corvocet Biopsy System
K153337 · KNW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 127d
Cleared Mar 22, 2016
Single Use Aspiration Needle NA-U401SX
K160098 · FCG
Olympus Medical Systems Corp.
Gastroenterology & Urology · 63d
Cleared Mar 21, 2016
Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip...
K160229 · FCG
Cook Ireland, Ltd.
Gastroenterology & Urology · 49d