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
2401–2424 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 04, 2012
JETPREP FLUSHING DEVICE OL-103037 / OL-133037 / OL-168037 / PE-105038 /...
K111274 · OCX
Jetprep, Ltd.
Gastroenterology & Urology · 335d
Cleared Apr 04, 2012
MAXIFLEX - SEMI FLEX SCOPE, 25 TO 65 CM
K111480 · FGB
Technology Delivery Systems, Inc.
Gastroenterology & Urology · 313d
Cleared Apr 04, 2012
MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER
K120674 · MPB
Covidien
Gastroenterology & Urology · 30d
Cleared Mar 30, 2012
URETRON MODEL URT
K111058 · FFK
Med-Sonics Corp.
Gastroenterology & Urology · 347d
Cleared Mar 29, 2012
ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION...
K112863 · KNT
Acta Medical, LLC
Gastroenterology & Urology · 181d
Cleared Mar 29, 2012
ACDS
K120005 · KPO
Isopure, Corp.
Gastroenterology & Urology · 86d
Cleared Mar 29, 2012
MCOMPASS ANORECTAL MANOMETRY SYSTEM
K120088 · KLA
Medspira, LLC
Gastroenterology & Urology · 78d
Cleared Mar 28, 2012
AQUASHIELD CO2 SYSTEM
K120123 · FEQ
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 71d
Cleared Mar 22, 2012
AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET...
K111702 · LKN
Fenwal, Inc.
Gastroenterology & Urology · 279d
Cleared Mar 20, 2012
V1 SYSTEM
K111756 · FDF
Olympus Medical Systems Corp.
Gastroenterology & Urology · 272d
Cleared Mar 20, 2012
MAMMOTOME ELITE BIOPSY SYSTEM
K112411 · KNW
Devicor Medical Products, Inc.
Gastroenterology & Urology · 211d
Cleared Mar 19, 2012
CODAN SAFEFEED ENTERAL FEEDING RESERVOIR
K112268 · KNT
Codan US Corp.
Gastroenterology & Urology · 224d
Cleared Mar 19, 2012
PLEURX PERITONEAL CATHETER SYSTEM
K113854 · PNG
Care Fusion
Gastroenterology & Urology · 81d
Cleared Mar 13, 2012
VETA PERITONEAL DIALYSIS CATHETER
K113354 · FJS
Pfm Medical, Inc.
Gastroenterology & Urology · 120d
Cleared Mar 09, 2012
HEMO-CATH 10F, HEMO-CATH 12.5F
K113487 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 107d
Cleared Mar 08, 2012
THE ONCONTROL BONE ACCESS AND BONE BIOPSY SYSTEM BY VIDACARE
K113872 · KNW
Vidacare Corporation
Gastroenterology & Urology · 69d
Cleared Mar 06, 2012
FRESENIUS 2008T HEMODIALYSIS MACHINE
K120505 · KDI
Fresenius Medical Care North America,...
Gastroenterology & Urology · 14d
Cleared Mar 01, 2012
DUET MAGNA
K111947 · LNS
Direx Systems Corp.
Gastroenterology & Urology · 237d
Cleared Feb 23, 2012
INVENDO C20 COLONOSCOPY SYSTEM
K100624 · FDF
Invendo Medical Gbmh
Gastroenterology & Urology · 721d
Cleared Feb 22, 2012
INCONTROL
K110179 · KPI
Incontrol Medical, LLC
Gastroenterology & Urology · 397d
Cleared Feb 22, 2012
BONETRAP
K120189 · KNW
Berni Farns Incorporated
Gastroenterology & Urology · 30d
Cleared Feb 17, 2012
ACE STAPLER AND CARTRIDGE
K120147 · OCW
Barosense, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 17, 2012
AMERITUS MEDICAL ENTERAL FEEDING EXTENSION SET
K120272 · KNT
Kentec Medical, Inc.
Gastroenterology & Urology · 18d
Cleared Feb 16, 2012
WAVES
K111521 · KDN
Waters Medical Systems, LLC
Gastroenterology & Urology · 260d