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
6865–6888 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jun 11, 1990
CORPAK GASTROSTOMY TUBE
K901501 · KGC
Corpak Co.
Gastroenterology & Urology · 73d
Cleared Jun 08, 1990
HOME URODATA SYSTEM(TM)
K900770 · EXY
Biodan Medical Systems, Ltd.
Gastroenterology & Urology · 112d
Cleared Jun 08, 1990
DURACATH
K901133 · LFJ
Impra, Inc.
Gastroenterology & Urology · 88d
Cleared Jun 08, 1990
MODIFIED PROXIMA MONITOR/DIGITRAPPER ED UNIT
K902366 · FFT
Synectics-Dantec
Gastroenterology & Urology · 23d
Cleared Jun 07, 1990
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
K891007 · KPI
Tridak Division of Indicon, Inc.
Gastroenterology & Urology · 465d
Cleared Jun 06, 1990
SUPER STRENGTH DENTURE ADHESIVE CREAM
K901938 · KOB
Teledyne Getz
Gastroenterology & Urology · 37d
Cleared Jun 05, 1990
SOFT, SPRING TIPPED NYLON COATED GUIDE WIRE
K901429 · OCY
Telemed Systems, Inc.
Gastroenterology & Urology · 71d
Cleared Jun 01, 1990
ENTERA-FLO FEEDING TUBE
K901130 · KNT
Fresenius Pharma
Gastroenterology & Urology · 81d
Cleared Jun 01, 1990
RIGID URETEROSCOPE
K901214 · FGB
Applied Urology, Inc.
Gastroenterology & Urology · 79d
Cleared Jun 01, 1990
600 OR 1200 ML. ENTERAL BAG ADMINISTRATION SET
K901753 · KNT
Chartermed, Inc.
Gastroenterology & Urology · 46d
Cleared Jun 01, 1990
URESIL TRU-CLOSE DRAINAGE BAG
K901844 · EXF
Uresil Corp.
Gastroenterology & Urology · 38d
Cleared Jun 01, 1990
FILTERTEK PN 60650 DIALYSIS TRANSDUCER PROTECTOR
K901996 · FIB
Filtertek, Inc.
Gastroenterology & Urology · 30d
Cleared May 24, 1990
ASI TCU PROSTATIC URETHROPLASTY CATHETER & ACCESS.
K896713 · KOE
Advanced Surgical Intervention, Inc.
Gastroenterology & Urology · 176d
Cleared May 22, 1990
FLEXIBLE CHOLEDOCHOSCOPE
K901010 · FBN
Intramed Laboratories, Inc.
Gastroenterology & Urology · 78d
Cleared May 22, 1990
SUB-CLAVIAN CATHETERS SLSC 1300, 1500 AND 2000
K901061 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 78d
Cleared May 18, 1990
AMICON HEMOCONCENTRATOR SET
K901286 · KDI
Amicon, Inc.
Gastroenterology & Urology · 59d
Cleared May 17, 1990
AMS OPTILUME INFLATION SYRINGE
K900760 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
AMS OPTILUME(TM) PROSTATE BALLOON DILATOR
K900761 · KOE
American Medical Systems, Inc.
Gastroenterology & Urology · 90d
Cleared May 17, 1990
BARD SHORT RIGID URETEROSCOPE
K900813 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 85d
Cleared May 15, 1990
MEDILASE 5010 ENDOSCOPE CONSOLE
K900380 · FET
Medical Laser, Inc.
Gastroenterology & Urology · 109d
Cleared May 15, 1990
HEMODIALYSIS TRANSDUCER PROTECTOR
K900841 · FIB
Mediflex Intl.
Gastroenterology & Urology · 82d
Cleared May 11, 1990
CANDELA DIRECTABLE BILIARY CATHETER SYSTEM
K900904 · FGE
Candela Laser Corp.
Gastroenterology & Urology · 73d
Cleared May 09, 1990
DUALYSE-CATH - CODES #1132.212, 1132.112
K896568 · LFJ
Vygon Corp.
Gastroenterology & Urology · 170d
Cleared May 09, 1990
MODIFIED PERM-CATH
K900835 · LFJ
Quinton, Inc.
Gastroenterology & Urology · 76d