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
4081–4104 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 12, 2001
ULTRAFLEX ESOPHAGEAL STENT SYSTEM, ULTRAFLEX DIAMONDBILIARY STENT SYSTEM,...
K012883 · ESW
Boston Scientific Corp
Gastroenterology & Urology · 45d
Cleared Oct 11, 2001
BRIDGE SE SELF-EXPANDING STENT DELIVERY SYSTEM
K011080 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 185d
Cleared Oct 10, 2001
GAMBRO POLYFLUX 6L, GAMBRO POLYFLUX 8L, GAMBRO POLYFLUX 10L, MODEL 6L, 8L, 10L
K010985 · KDI
Gambro Renal Products
Gastroenterology & Urology · 191d
Cleared Oct 05, 2001
THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
K010706 · MNW
Measurement Specialties, Inc.
Gastroenterology & Urology · 210d
Cleared Oct 05, 2001
MODIFICATION TO PRECISE NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K012993 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 04, 2001
DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL...
K012235 · KPM
Denver Biomedical, Inc.
Gastroenterology & Urology · 79d
Cleared Oct 04, 2001
URETEX SUP PUBOURETHRAL SLING
K012949 · OTN
Sofradim Production
Gastroenterology & Urology · 30d
Cleared Oct 03, 2001
MEDCOMP EXCELL SPLIT TIP CATHETER
K010306 · MSD
Medcomp
Gastroenterology & Urology · 244d
Cleared Oct 03, 2001
MODIFICATION TO VAXCEL DIALYSIS CATHETER
K012948 · MSD
Boston Scientific/Medi-Tech
Gastroenterology & Urology · 29d
Cleared Oct 03, 2001
HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-24, HFS-28, HFS-32, HFS-36, HFS-40
K994105 · MSD
Medical Components, Inc.
Gastroenterology & Urology · 667d
Cleared Sep 28, 2001
AQUA WATER TREATMENT FOR HEMODIALYSIS
K010592 · FIP
Aqua Water Treatment, Inc.
Gastroenterology & Urology · 212d
Cleared Sep 27, 2001
DIALYSATE LINE WITH CONNECTORS/RE-USE WASH-OUT LINES
K010712 · FID
Molded Products, Inc.
Gastroenterology & Urology · 202d
Cleared Sep 27, 2001
VANGUARD REPROCESSED ELECTRIC BIOPSY FORCEPS
K011800 · NLU
Vanguard Medical Concepts, Inc.
Gastroenterology & Urology · 111d
Cleared Sep 25, 2001
XBO1-824-18/19/20 BIOPSY FORCEPS
K012074 · OCZ
The Olympus Optical Co.
Gastroenterology & Urology · 85d
Cleared Sep 21, 2001
LH 450 ENTERAL FEEDING BAG PUMP SET W/INTEGRATED Y-PORT
K011340 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH400 YES-SET Y-PORT ENTERAL SPIKE PUMP SET
K011341 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 21, 2001
LH 500 ENTERAL FEEDING GRAVITY BAG SET
K011343 · KNT
Lh Medical Products, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 19, 2001
LOWSLEY SUPRAPUBIC TRACTOR
K012153 · KOB
Circon Video
Gastroenterology & Urology · 70d
Cleared Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES,...
K011911 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Sep 12, 2001
ANCHOR GUIDE LESION LOCALIZATION DEVICE
K012023 · KNW
Senorx, Inc.
Gastroenterology & Urology · 76d
Cleared Sep 11, 2001
CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
K011848 · FFK
Circon Video
Gastroenterology & Urology · 90d
Cleared Sep 10, 2001
AQUANET, MODEL EC 2000
K000031 · KPL
Prime Pacific Health Innovations...
Gastroenterology & Urology · 614d
Cleared Sep 07, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K011806 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 88d
Cleared Sep 07, 2001
CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT ON OPTA PRO .035 DELIVERY...
K012590 · FGE
Cordis Corp.
Gastroenterology & Urology · 28d