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
5737–5760 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Dec 23, 1994
KARL STORZ TELESCOPE BRIDGES AND ADAPTERS
K945527 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 43d
Cleared Dec 21, 1994
KARL STORZ HOPKINS I&II/OPER/AUTOCLAVABLE TELESCOPESQ
K943176 · FAJ
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 173d
Cleared Dec 21, 1994
KARL STORZ UNIPOLAR BALL, NEEDLE, LOOP ELECTRODES
K944795 · FAS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 84d
Cleared Dec 21, 1994
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K944944 · FCG
Promedical , Ltd.
Gastroenterology & Urology · 75d
Cleared Dec 21, 1994
CHIBA, FRANSEEN, WESTCOTT, SPINAL STYLE ASPIRATION BIOPSY NEEDLE
K945146 · FCG
Promex, Inc.
Gastroenterology & Urology · 62d
Cleared Dec 15, 1994
GIP/MEDI-GLOBE GOREIGN BODY GRASPERS
K943476 · OCZ
Medi-Globe Corp.
Gastroenterology & Urology · 149d
Cleared Dec 15, 1994
INSUFFLATOR FILTER TUBING SET
K945970 · FCX
Xylog Corp.
Gastroenterology & Urology · 7d
Cleared Dec 13, 1994
MODEL 5135 AUTO LP/FLASH
K944607 · GCT
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 85d
Cleared Dec 09, 1994
BIOPSY DEVICE ACCESSORY
K945573 · KNW
Biopsys Medical, Inc.
Gastroenterology & Urology · 25d
Cleared Dec 08, 1994
SLIP-COAT STENTS
K930731 · FAD
Cook Urological, Inc.
Gastroenterology & Urology · 665d
Cleared Dec 08, 1994
PEANUT WAND, MODIFICATION
K944067 · GCS
Ideal Medical, Inc.
Gastroenterology & Urology · 135d
Cleared Dec 08, 1994
CATHETERS, BILIARY CATHETERS, UROLOGICAL
K944290 · FFA
Boston Scientific Corp
Gastroenterology & Urology · 97d
Cleared Dec 08, 1994
CHAKOFF ENDOSCOPY
K945420 · FCW
Stephen Chakoff, Inc.
Gastroenterology & Urology · 34d
Cleared Dec 06, 1994
ORION'S URINARY DRAINAGE SET
K944377 · KNX
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 1994
ORION ALL SILICONE FOLEY CATHETER
K944382 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 06, 1994
ORION RED URETHRAL CATHETER
K944383 · EZD
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 90d
Cleared Dec 05, 1994
OVER THE GUIDEWIRE DILATATION SYSTEM
K924646 · KNQ
Medovations, Inc.
Gastroenterology & Urology · 812d
Cleared Dec 05, 1994
BIOPSY DEVICE ACCESSORY
K944252 · FCK
Biopsys Medical, Inc.
Gastroenterology & Urology · 97d
Cleared Nov 30, 1994
DEVMED DOUBLE-BALLOON UROLOGICAL CATHETER
K941488 · EZL
Medical Technology Development Corp.
Gastroenterology & Urology · 247d
Cleared Nov 30, 1994
OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES
K942338 · FDT
Olympus Corp.
Gastroenterology & Urology · 198d
Cleared Nov 30, 1994
OKTAS STEREO VIEWING SYSTEM
K944254 · FET
Oktas
Gastroenterology & Urology · 91d
Cleared Nov 30, 1994
ORION ALL SILICONE ELASTOMER COATED CATHETER
K944376 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1994
ORION FOLEY CATHETER
K944380 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d
Cleared Nov 30, 1994
ORION ALL SILICONE FOLEY CATHETER TEMPERATURE PROBE
K944381 · EZL
Regulatory & Marketing Services, Inc.
Gastroenterology & Urology · 84d