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
5065–5088 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Apr 15, 1997
VAGINAL 2 ELECTRODE STIMULATION/EMG PROBE-SMALL
K970602 · KPI
Hollister, Inc.
Gastroenterology & Urology · 56d
Cleared Apr 14, 1997
DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER
K962814 · KPM
Denver Biomaterials, Inc.
Gastroenterology & Urology · 269d
Cleared Apr 11, 1997
MICROVASIVE GOLD PROBE
K970278 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 11, 1997
OLYMPUS NA-10J-1 ASPIRATION NEEDLE
K970563 · FCG
Olympus America, Inc.
Gastroenterology & Urology · 57d
Cleared Apr 03, 1997
URODYNAMIC ANALYSIS MODULE
K963330 · FAP
Synectics Medical, Inc.
Gastroenterology & Urology · 223d
Cleared Apr 03, 1997
12 URETEROSCOPES/URETERO-RENOSCOPES
K963855 · FGB
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 190d
Cleared Apr 02, 1997
STONE DISLODGER, BASKET
K970121 · FGO
Boston Scientific Corp
Gastroenterology & Urology · 78d
Cleared Apr 02, 1997
VISTA ILLUMINATION SYSTEM
K970217 · FFS
Vista Medical Technologies, Inc.
Gastroenterology & Urology · 71d
Cleared Apr 02, 1997
MENTOR UROLOGY TRIPLE RIB OCCLUSION WRAP FOR MALE INCONTINENCE
K970308 · FHA
Mentor Urology, Inc.
Gastroenterology & Urology · 65d
Cleared Mar 28, 1997
ERCP CANNULA
K963051 · ODD
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 234d
Cleared Mar 28, 1997
ULTRATOMERX
K970053 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 80d
Cleared Mar 28, 1997
MAMMOTOME BIOPSY PROBE AND HOUSING (MAMMOTOME)
K970565 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Mar 28, 1997
COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM
K971057 · GCT
Cogent Light Technologies, Inc.
Gastroenterology & Urology · 4d
Cleared Mar 27, 1997
PNEUMO-MATIC INSUFFLATION NEEDLE
K970788 · FHO
Apple Medical Corp.
Gastroenterology & Urology · 23d
Cleared Mar 25, 1997
BENTLEY QUICK-PRIME HEMOCONCENTRATOR WITH DURAFLO TREATMENT
K963203 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 222d
Cleared Mar 25, 1997
EXTRACTORRX
K970052 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 77d
Cleared Mar 25, 1997
IRRIGATION/ASPIRATION POLYPECTOMY
K970356 · FDI
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 54d
Cleared Mar 25, 1997
CORE AND COIL ASSEMBLY GUIDEWIRE
K970994 · EZB
Lake Region Mfg., Inc.
Gastroenterology & Urology · 6d
Cleared Mar 21, 1997
ELLIPSE 4
K964522 · FEN
Andromeda Medizinische Systeme GmbH
Gastroenterology & Urology · 129d
Cleared Mar 21, 1997
LIBERTY VALVE
K964690 · KNX
Cleveland Medical Devices, Inc.
Gastroenterology & Urology · 119d
Cleared Mar 20, 1997
SURE CORE BIOPSY KIT
K963813 · KNW
Interventional Concepts, Inc.
Gastroenterology & Urology · 178d
Cleared Mar 19, 1997
NIKKISO CO, LTD., FLX10GW, 12GW, 15GW, 18GW & 21GW HEMODIALYZERS
K953996 · KDI
NIKKISO CO., LTD.
Gastroenterology & Urology · 573d
Cleared Mar 19, 1997
OMNITECH RESECTOSCOPE ROLLER ELECTRODE
K965093 · FAS
Omnitech Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 19, 1997
ASCEND BALLOON DAILATION CATHETER
K970041 · EZN
Cook Urological, Inc.
Gastroenterology & Urology · 72d