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
6529–6552 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Jul 26, 1991
URETERAL CATHETER HOLDER
K912146 · KNY
Inman Liebelt Corp.
Gastroenterology & Urology · 72d
Cleared Jul 26, 1991
COX DIAPOSABLE POLYPECTOMY SNARE
K912254 · FDI
Cox Medical Ent., Inc.
Gastroenterology & Urology · 66d
Cleared Jul 24, 1991
BARD REPLACEMENT GASTROSTOMY TUBE
K910492 · KGC
C.R. Bard, Inc.
Gastroenterology & Urology · 169d
Cleared Jul 24, 1991
GASPARAITIS ESOPHAGRAM CATHETER SET
K911897 · KNT
E-Z-Em, Inc.
Gastroenterology & Urology · 86d
Cleared Jul 24, 1991
FRESENIUS SAFE-CONNECT CAPD MANUAL ASSIST DEVICE
K912208 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 65d
Cleared Jul 23, 1991
TRIP(TM) NASOGASTRIC SUMP CATHETER
K911825 · FFT
Tonometrics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 19, 1991
ENTREE CANNULA
K911813 · FBM
Core Dynamics, Inc.
Gastroenterology & Urology · 87d
Cleared Jul 17, 1991
GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXING
K911459 · KPO
Fresenius USA, Inc.
Gastroenterology & Urology · 105d
Cleared Jul 15, 1991
TBD
K910081 · KPI
Empi
Gastroenterology & Urology · 187d
Cleared Jul 11, 1991
REDFIELD INFRARED COAGULATOR
K911648 · KNS
Redfield Corp.
Gastroenterology & Urology · 90d
Cleared Jul 09, 1991
ILCO INFRARED LIGHT COAGULATOR
K911600 · KNS
Holl Meditronics, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 09, 1991
SPACE(TM) 7500
K912071 · IKN
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 60d
Cleared Jul 05, 1991
ACETATE-FREE DIALYSLATE SOLUTION
K903835 · KPO
Physio, Inc.
Gastroenterology & Urology · 318d
Cleared Jul 01, 1991
MONOPOLAR POLLYPECTOMY SNARE
K911700 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 76d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (1.O% -2.0%)
K911628 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 27, 1991
SERIM FORMALDEHYDE REAGENT STRIPS (2.5% -4.0%)
K911629 · LIF
Serim Research Corp.
Gastroenterology & Urology · 77d
Cleared Jun 25, 1991
SURGITEK(R) ERCP CONTRAST MEDIA SYSTEM
K910769 · ODD
Surgitek Medical Engineering Corp.
Gastroenterology & Urology · 123d
Cleared Jun 24, 1991
MOSS- ANCHOR SET
K910910 · KNT
Moss Medical Products
Gastroenterology & Urology · 111d
Cleared Jun 24, 1991
IRRIGATION/ASPIRATION TUBING SET
K911324 · KDH
Biomedical Dynamics, Inc.
Gastroenterology & Urology · 90d
Cleared Jun 20, 1991
MEDISYSTEMS HEMODIALYSIS FISTULA SET
K910734 · FIE
Medisystems Corp.
Gastroenterology & Urology · 119d
Cleared Jun 20, 1991
FLEXIBLE CHOLEDOCHOSCOPE
K911480 · FBN
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 77d
Cleared Jun 20, 1991
MEADOX(R) SURGIMED(R) BIOPSY GUN II
K911635 · KNW
Meadox Surgimed, Inc.
Gastroenterology & Urology · 70d
Cleared Jun 20, 1991
BIPROBE(TM)
K912601 · KNS
C.R. Bard, Inc.
Gastroenterology & Urology · 10d
Cleared Jun 19, 1991
GASTROSCAN
K905154 · FFX
Medics Instrument Corp.
Gastroenterology & Urology · 216d