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
6193–6216 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Mar 12, 1993
PEG GASTROSTOMY TUBE KIT
K915308 · FPD
Sandoz Nutrition
Gastroenterology & Urology · 477d
Cleared Mar 05, 1993
HOLLOW FIBER DIALYZER FOCUS 9OR/90H-R/120R/120H-R
K914790 · FJI
National Medical Care, Medical...
Gastroenterology & Urology · 499d
Cleared Mar 05, 1993
ILLUMINATED URETERAL CATHETER
K923436 · FCS
Cook Urological, Inc.
Gastroenterology & Urology · 235d
Cleared Mar 05, 1993
HYDROPHILIC COATED GUIDEWIRE
K926344 · KNY
Surgitek
Gastroenterology & Urology · 78d
Cleared Mar 03, 1993
DRITRAINER
K930005 · KPN
Laborie Medical Technologies, Ltd.
Gastroenterology & Urology · 58d
Cleared Mar 02, 1993
JMS APHERESIS NEEDLE
K915174 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 473d
Cleared Mar 02, 1993
PLASMA DISCARD BAGS
K926409 · LKN
Apheresis Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Feb 26, 1993
ACUCISE URETERAL CUTTING CATHETER
K921838 · EYB
Applied Urology, Inc.
Gastroenterology & Urology · 315d
Cleared Feb 26, 1993
OMEGASCOPE
K924228 · FBN
Omega Universal Technologies, Ltd.
Gastroenterology & Urology · 189d
Cleared Feb 25, 1993
UROTECH CATHETER
K911617 · EZL
Urotech U.S.A., Inc.
Gastroenterology & Urology · 686d
Cleared Feb 25, 1993
FRESENIUS VARIABLE FILL MONITOR
K921052 · KDJ
Fresenius USA, Inc.
Gastroenterology & Urology · 357d
Cleared Feb 22, 1993
CAVERNOSOMETRY MODULE FOR MENUET
K923117 · DXT
Dantec Medical, Inc.
Gastroenterology & Urology · 241d
Cleared Feb 19, 1993
FLEXIBLE FIBER OPTIC ENDOSCOPE
K922826 · FGA
Optimed Technologies, Inc.
Gastroenterology & Urology · 253d
Cleared Feb 17, 1993
CAMSYS 6300
K920574 · EXQ
F.M. Wiest USA, Inc.
Gastroenterology & Urology · 376d
Cleared Feb 16, 1993
BARD MONOPTY DISPOSABLE CORE BIOPSY ISNT. W/ CENT.
K922939 · KNW
C.R. Bard, Inc.
Gastroenterology & Urology · 243d
Cleared Feb 12, 1993
PRESSURE TURING AND ACCESSORIES
K925918 · GCM
Applied Medical Resources
Gastroenterology & Urology · 81d
Cleared Feb 10, 1993
ENDOSCOPE AND ACCOSSORIES
K926004 · FGB
Endomedix
Gastroenterology & Urology · 75d
Cleared Feb 08, 1993
COLONOSCOPIC INJECTION NEEDLE, C-323/C-325
K921800 · FBK
Mill-Rose Laboratory
Gastroenterology & Urology · 300d
Cleared Feb 08, 1993
MICROVASIVE INSURG FLAT WIRE BASKETS
K925879 · LQR
Boston Scientific Corp
Gastroenterology & Urology · 81d
Cleared Feb 05, 1993
URODYNAMIC CATHETERS
K923464 · FAP
R.L. Medical Corp.
Gastroenterology & Urology · 206d
Cleared Feb 02, 1993
HEMO-CATH SILICONE ACCESS CATHETER
K915423 · LFJ
Medical Components, Inc.
Gastroenterology & Urology · 428d
Cleared Jan 28, 1993
DIGI -FLOW
K920671 · KOC
D and D Technology, Inc.
Gastroenterology & Urology · 350d
Cleared Jan 28, 1993
AUTOLITH-IEHL
K923822 · FFK
Northgate Technologies, Inc.
Gastroenterology & Urology · 182d
Cleared Jan 21, 1993
HAND PACK
K914934 · KDO
Westmark Hospital Supplies
Gastroenterology & Urology · 444d