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
2017–2040 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 10, 2014
KEGEL SMART, KEGELSMART PEARL
K140780 · HIR
Regulatory Insight, Inc.
Gastroenterology & Urology · 166d
Cleared Sep 09, 2014
FUJIFILM ENDOSCOPIC CO2 REGULATOR
K133976 · FCX
Fujifilm Medical System U.S.A., Inc.
Gastroenterology & Urology · 257d
Cleared Sep 05, 2014
ACHIEVE PROGRAMMABLE AUOMATED BIOPSY SYSTEMS
K141552 · KNW
Care Fusion
Gastroenterology & Urology · 86d
Cleared Sep 04, 2014
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · KNW
Stryker Corporation
Gastroenterology & Urology · 73d
Cleared Sep 04, 2014
COMPAT ENTERAL DELIVERY PUMP SETS
K140947 · PIF
Nestle Healthcare Nutrition, Inc.
Gastroenterology & Urology · 143d
Cleared Aug 26, 2014
VERITRACT ENTERAL FEEDING TUBE SYSTEM
K133334 · KNT
Veritract, Inc.
Gastroenterology & Urology · 301d
Cleared Aug 22, 2014
VAPRO INTERMITTENT CATHETER
K141642 · GBM
Hollister Incorporated
Gastroenterology & Urology · 64d
Cleared Aug 22, 2014
MUSTANG BALLOON DIALATION CATHETER
K141597 · FGE
Boston Scientific Corporation
Gastroenterology & Urology · 70d
Cleared Aug 22, 2014
COMPACTCATH INTERMITTENT URINARY CATHETER
K140945 · EZD
Compactcath, Inc.
Gastroenterology & Urology · 130d
Cleared Aug 22, 2014
EPX-4440HD DIGITAL VIDEO PROCESSOR
K140149 · PEA
Fujifilm Medical Systems U.S.A, Inc.
Gastroenterology & Urology · 212d
Cleared Aug 14, 2014
CRIT-LINE CLIP (CLIC) BLOOD CHAMBER
K141281 · KOC
Fresenius Medical Care Renal...
Gastroenterology & Urology · 90d
Cleared Aug 07, 2014
VISERA CYSTO-NEPHRO VIDEOSCOPE OLYMPUS CYF TYPE V2, VISERA CYSTO-NEPHRO...
K133538 · NWB
Olympus Corporation of the Americas
Gastroenterology & Urology · 262d
Cleared Aug 01, 2014
ENSIZOR ENDOSCOPIC SCISSORS
K141058 · OCZ
Slater Endoscopy, LLC
Gastroenterology & Urology · 99d
Cleared Aug 01, 2014
GENTLECATH MALE COUDE OLIVE TIP INTERMITTENT URINARY CATHETER
K140953 · KOD
Convatec, Ltd.
Gastroenterology & Urology · 109d
Cleared Jul 30, 2014
LIBERTY PDX CYCLER
K141145 · FKX
Fresenius Medical Care Renal...
Gastroenterology & Urology · 89d
Cleared Jul 30, 2014
ENDOLED
K133311 · NTN
Olympus Winter & Ibe GmbH
Gastroenterology & Urology · 275d
Cleared Jul 28, 2014
AQUARIUS EXTENSION FEEDING SET
K141631 · KNT
Degania Silicone , Ltd.
Gastroenterology & Urology · 40d
Cleared Jul 28, 2014
GENERICA MEDICAL ENTERNAL DELIVERY
K133077 · KNT
Generica Medical International, Inc.
Gastroenterology & Urology · 301d
Cleared Jul 24, 2014
RE-TRACE URETERAL ACCESS SHEATH, 12/14 CH/FR, LENGTH 35 CM, LENGTH 45 CM
K140523 · FED
Coloplast A/S
Gastroenterology & Urology · 142d
Cleared Jul 24, 2014
GIS ENDOSCOPIC OPTICAL LENS
K140295 · FDS
Gi Scientific, LLC
Gastroenterology & Urology · 168d
Cleared Jul 24, 2014
NOVAPROBE LED LIGHT SOURCE
K131226 · FCW
Novaprobe Incorporated
Gastroenterology & Urology · 450d
Cleared Jul 22, 2014
EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER, COMED ASADAL-M1
K131721 · LNS
Comed Medical Systems Co., Ltd.
Gastroenterology & Urology · 405d
Cleared Jul 21, 2014
CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR...
K140726 · FDI
Boston Scientific Corp
Gastroenterology & Urology · 119d
Cleared Jul 16, 2014
PROCTIGARD
K140558 · PHN
Access Pharmaceuticals, Inc.
Gastroenterology & Urology · 133d