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
3385–3408 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 15, 2005
STRYKER FLEXIBLE CYSTONEPHROSCOPE
K043022 · FAJ
Stryker Endoscopy
Gastroenterology & Urology · 132d
Cleared Mar 15, 2005
PRO FIT DISPOSABLE RECTAL SPECULUM, MODELS 8116 AND 8117
K050112 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 56d
Cleared Mar 14, 2005
MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050501 · FGE
Abbott Vascular Devices
Gastroenterology & Urology · 14d
Cleared Mar 11, 2005
RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR
K050232 · PID
Boston Scientific Corp
Gastroenterology & Urology · 38d
Cleared Mar 09, 2005
WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K042797 · FIP
Gambro Renal Products
Gastroenterology & Urology · 152d
Cleared Mar 09, 2005
MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT
K050148 · OTN
Mentor Corporation
Gastroenterology & Urology · 44d
Cleared Mar 08, 2005
FX WIRE ADVANCED MEASUREMENT GUIDEWIRE
K050304 · OCY
Conmedcorp
Gastroenterology & Urology · 28d
Cleared Mar 04, 2005
SPYGLASS DIRECT VISULATION PROBE
K050403 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 15d
Cleared Mar 03, 2005
DUAL LUMEN CATHETER
K043581 · EYB
Acmi Corporation
Gastroenterology & Urology · 65d
Cleared Feb 28, 2005
MUELLER WATER CONDITIONING WATER PURIFICATION SYSTEM FOR HEMODIALYSIS
K041884 · FIP
Mueller Water Conditioning, Inc.
Gastroenterology & Urology · 231d
Cleared Feb 28, 2005
CUSTODIOL
K043461 · KDL
Dr. Franz Kohler Chemie GmbH
Gastroenterology & Urology · 75d
Cleared Feb 28, 2005
USGI SHAPELOCK ENDOSCOPIC GUIDE
K050253 · FED
Usgi Medical
Gastroenterology & Urology · 25d
Cleared Feb 25, 2005
BEAMCATH
K042110 · EZL
Beampoint AB
Gastroenterology & Urology · 204d
Cleared Feb 16, 2005
XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
K050103 · FGE
Abbott Laboratories
Gastroenterology & Urology · 29d
Cleared Feb 14, 2005
BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY...
K033862 · FGE
Bioteque Corp.
Gastroenterology & Urology · 430d
Cleared Feb 14, 2005
MEDISISS REPROCESSED NON-ELECTRIC GI BIOPSY FORCEPS
K042659 · NON
Medisiss
Gastroenterology & Urology · 139d
Cleared Feb 11, 2005
INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE
K043523 · KNW
Medical Device Technologies, Inc.
Gastroenterology & Urology · 53d
Cleared Feb 10, 2005
PATHWAY URETERAL ACCESS SHEATH, PATHWAY EXPANDABLE URETERAL ACCESS SHEATH
K043254 · EZN
Onset Medical Corporation
Gastroenterology & Urology · 78d
Cleared Feb 09, 2005
HL 188 & HL 189 BODY FAT METER
K043414 · MNW
Health & Life Co., Ltd.
Gastroenterology & Urology · 58d
Cleared Feb 08, 2005
EASY CORE BIOPSY SYSTEM II
K050120 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 21d
Cleared Feb 04, 2005
INSCOPE 3-STAGE BALLOON DILATOR
K043605 · KNQ
Cordis Europa, N.V.
Gastroenterology & Urology · 36d
Cleared Feb 03, 2005
MEDCOMP SPLIT-CATH II
K040318 · MSD
Medcomp
Gastroenterology & Urology · 360d
Cleared Feb 03, 2005
NEOSCOPE - ENDOSCOPIC DIAGNOSTIC & TREATMENT SYSTEM
K042780 · FAJ
Prosurg, Inc.
Gastroenterology & Urology · 120d
Cleared Feb 03, 2005
ASSIST HEADER CLEANER
K043126 · LIF
Alcavis International, Inc.
Gastroenterology & Urology · 83d