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
3097–3120 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 09, 2007
EXPRESSWAY INTERMITTENT CATHETER
K061766 · EZD
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 260d
Cleared Mar 09, 2007
ENDOGASTRIC STOMAPHYX DEVICE AND ACCESSORIES
K062875 · OCW
Endogastric Solutions, Inc.
Gastroenterology & Urology · 164d
Cleared Mar 09, 2007
ECONOLITH EM1000
K063504 · LNS
Medispec, Ltd.
Gastroenterology & Urology · 109d
Cleared Mar 09, 2007
BARDEX LUBRI-SIL ALL-SILICONE LUBRICIOUS COATED FOLEY CATHETER 6 FR
K070508 · EZL
C.R. Bard, Inc.
Gastroenterology & Urology · 15d
Cleared Mar 07, 2007
TROKABONE, TROKABONE STERNAL
K070179 · FCG
PAJUNK GmbH Medizintechnologie
Gastroenterology & Urology · 47d
Cleared Mar 05, 2007
PS SERIES
K061622 · FFS
Photonic Optische Gerate Gesmbh & Cokg
Gastroenterology & Urology · 266d
Cleared Mar 05, 2007
ENDOSCOPIC INSUFFLATION UNIT, MODEL XECR-2
K063786 · FCX
Olympus Medical Systems Corporation
Gastroenterology & Urology · 74d
Cleared Mar 05, 2007
GUARDIANCATHETER-URINARY DRAINAGE CATHETER
K063795 · GBM
Marian Medical, Inc.
Gastroenterology & Urology · 73d
Cleared Mar 02, 2007
FLEXILUX II CYSTOSCOPE AND HYSTEROSCOPE
K060899 · FAJ
Schoelly Imaging, Inc.
Gastroenterology & Urology · 333d
Cleared Mar 01, 2007
AMS SINGLE INCISION SLING SYSTEM (SIS-0)
K070065 · PAH
American Medical Systems, Inc.
Gastroenterology & Urology · 52d
Cleared Feb 22, 2007
HI-SLIP AND HI-SLIP PLUS SINGLE USE HYDROPHILIC URINARY CATHETERS AND KIT
K062444 · EZD
Oasis Medikal Urunler Kimya Sanayi VE...
Gastroenterology & Urology · 185d
Cleared Feb 22, 2007
AMS SMART SLING SYSTEM
K063713 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 70d
Cleared Feb 15, 2007
BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230
K062603 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 167d
Cleared Feb 15, 2007
PRISMA M10 PRE SET
K063183 · KDI
Gambro Renal Products, Inc.
Gastroenterology & Urology · 119d
Cleared Feb 14, 2007
SPECIAL SPROTTE, CHIBA, DR STEINHOFF KIT
K063697 · KNW
PAJUNK GmbH Medizintechnologie
Gastroenterology & Urology · 63d
Cleared Feb 13, 2007
BARD BALLOON DILATION KIT WITH TRIFUNNEL GASTROSTOMY TUBE
K063118 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 125d
Cleared Feb 12, 2007
MEDISYSTEMS ARTERIAL-VENOUS FISTULA NEEDLE SET WITH SECUREMENT DEVICE
K062953 · FIE
Medisystems Corp.
Gastroenterology & Urology · 136d
Cleared Feb 12, 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28,...
K063441 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 08, 2007
HEMOCATH II
K062901 · MSD
Med-Conduit, Inc.
Gastroenterology & Urology · 134d
Cleared Feb 08, 2007
SPYGLASS IRRIGATION SYSTEM
K063700 · LJH
Medical Scientific, Inc.
Gastroenterology & Urology · 57d
Cleared Feb 05, 2007
NIPRO BIOHOLE NEEDLE
K063368 · FIE
Nipro Medical Corp.
Gastroenterology & Urology · 90d
Cleared Jan 31, 2007
REPROCESSED TROCARS
K062497 · NLM
Ascent Healthcare Solutions
Gastroenterology & Urology · 159d
Cleared Jan 31, 2007
KARL STORZ VIDEO LOWER G.I. ENDOSCOPE SYSTEM
K063585 · FDF
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 61d
Cleared Jan 31, 2007
ENDOGUIDE
K063654 · FDF
Kms Medical, LLC
Gastroenterology & Urology · 54d