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
6337–6360 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 16, 1992
DURA II PENILE PROSTHESIS
K920420 · FAE
Dacomed Corp.
Gastroenterology & Urology · 76d
Cleared Apr 16, 1992
BARD URETEROSCOPE DEFLECTION MODULE
K920750 · FGB
C.R. Bard, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 14, 1992
FLEXIFLO OVER-THE-GUIDEWIRE GASTROSTOMY KIT
K915110 · KNT
Abbott Laboratories
Gastroenterology & Urology · 153d
Cleared Apr 13, 1992
QUICVAGE PLUS
K914908 · KDH
Autovage
Gastroenterology & Urology · 164d
Cleared Apr 10, 1992
AKCESS-CATH KIT
K914826 · LFJ
Akcess Medical Products, Inc.
Gastroenterology & Urology · 168d
Cleared Apr 10, 1992
IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION
K920991 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED
K920992 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 10, 1992
MODEL 8100 URODYNAMICS MEASURING SYSTEM
K921047 · FAP
Browne Medical Systems, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 09, 1992
SERIM RESIDUAL FORMALDEHYDE REAGENT STRIPS
K914123 · LIF
Serim Research Corp.
Gastroenterology & Urology · 209d
Cleared Apr 08, 1992
CATHETER WITH INTRODUCER AND SYRINGES
K915129 · GCA
Utah Pioneer Medical, Inc.
Gastroenterology & Urology · 147d
Cleared Mar 31, 1992
BARD(R) UROTACK(R) 210 MONITORING SYSTEM
K912374 · KOC
C.R. Bard, Inc.
Gastroenterology & Urology · 307d
Cleared Mar 31, 1992
URESIL LAPAROSCOPIC CHOLANGIOGRAPHY CATHETER
K915343 · GCA
Uresil Corp.
Gastroenterology & Urology · 126d
Cleared Mar 31, 1992
MONOPOLAR COAGULATING POLYPECTOMY SNARE
K920089 · KNS
Everest Medical Corp.
Gastroenterology & Urology · 83d
Cleared Mar 30, 1992
DRAIN/PRIMING/RECIRCULATION BAG
K913361 · KOC
Haemotronic, Inc.
Gastroenterology & Urology · 245d
Cleared Mar 30, 1992
DAVOL LAPAROSCOPIC CHOLANGIOGRAM CATHETER & KIT
K914755 · GCA
Davol, Inc.
Gastroenterology & Urology · 160d
Cleared Mar 27, 1992
CONTINUOUS ARTERIOVENOUS HEMOFILTRATION CATH. KITS
K915215 · LFK
Akcess Medical Products, Inc.
Gastroenterology & Urology · 130d
Cleared Mar 26, 1992
DENTOLOCK
K921071 · KOB
Dentmed , Ltd.
Gastroenterology & Urology · 20d
Cleared Mar 20, 1992
MODIFIED ASAHI PAN-SERIES HEMOFILTERS
K914020 · KDI
Asahi Medical Co., Ltd.
Gastroenterology & Urology · 193d
Cleared Mar 20, 1992
ENTRAC(TM) URETHRAL MEASURING CATHETER
K914905 · GBM
American Medical Systems, Inc.
Gastroenterology & Urology · 140d
Cleared Mar 20, 1992
OVER THE WIRE STONE BASKET
K915538 · LQR
Medical Dynamics, Inc.
Gastroenterology & Urology · 101d
Cleared Mar 18, 1992
AMS SPHINCTER 800 URINARY PROSTHESIS
K912934 · FAG
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Mar 18, 1992
AMS MALLEABLE 600 AND 600M PENILE PROSTHESIS
K912935 · FAE
American Medical Systems, Inc.
Gastroenterology & Urology · 257d
Cleared Mar 18, 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 110d
Cleared Mar 18, 1992
SURESEAL ENDOSCOPIC VALVE
K920030 · ODC
Applied Urology, Inc.
Gastroenterology & Urology · 75d