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
3289–3312 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Oct 28, 2005
HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM
K051276 · OCZ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 164d
Cleared Oct 27, 2005
N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110
K043383 · FBK
Physion, Inc.
Gastroenterology & Urology · 322d
Cleared Oct 17, 2005
URGENT PC NEUROMODULATION SYSTEM
K052025 · NAM
Uroplasty, Inc.
Gastroenterology & Urology · 82d
Cleared Oct 17, 2005
I-STOP MID-URETHRAL SLING, MODELS IS-1000, IS-2000, IS-3000, IS-4000
K052175 · OTN
Uroplasty, Inc.
Gastroenterology & Urology · 68d
Cleared Oct 13, 2005
EVIS EXERA 160A SYSTEM
K051645 · NWB
Olympus Medical Systems Corporation
Gastroenterology & Urology · 115d
Cleared Oct 12, 2005
ENTERAL FEEDING TUBE
K051480 · BSS
Biosearch Medical Products, Inc.
Gastroenterology & Urology · 131d
Cleared Oct 11, 2005
COOK IRELAND ECHOBRUSH
K052279 · FDX
Cook Ireland, Ltd.
Gastroenterology & Urology · 50d
Cleared Oct 11, 2005
MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER
K052440 · EZD
Mentor Corporation
Gastroenterology & Urology · 35d
Cleared Oct 06, 2005
14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY
K051584 · MSD
Kendall
Gastroenterology & Urology · 113d
Cleared Oct 05, 2005
FLEXIBLE VIDEO CYSTOSCOPE/CHOLEDOCHOSCOPE, MODELS 7308.061 AND 7308.066
K051176 · FAJ
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 152d
Cleared Sep 30, 2005
HEMOR-RITE CRYOTHERAPHY
K042564 · LKX
Fama Holdings International Corp
Gastroenterology & Urology · 374d
Cleared Sep 22, 2005
CYSTOGLIDE DILATING INTRODUCER SHEATH
K052134 · KNY
Percutaneous Systems, Inc.
Gastroenterology & Urology · 48d
Cleared Sep 14, 2005
ENDO-EASE ENDOSCOPIC OVERTUBE
K052084 · FED
Spirus Medical, Inc.
Gastroenterology & Urology · 43d
Cleared Sep 13, 2005
ACCORDION
K052048 · FFL
Percutaneous Systems, Incorporated
Gastroenterology & Urology · 46d
Cleared Sep 02, 2005
UROPASS URETERAL ACCESS SHEATH, MODEL 61224
K051593 · KNY
Acmi Corporation
Gastroenterology & Urology · 78d
Cleared Aug 30, 2005
ORS MODEL 6000 ENDOSCOPE HOLDER
K051979 · OCT
O.R. Solutions, Inc.
Gastroenterology & Urology · 40d
Cleared Aug 29, 2005
UROPLASTY RIGID ENDOSCOPIC NEEDLE
K051905 · FBK
Uroplasty, Inc.
Gastroenterology & Urology · 46d
Cleared Aug 25, 2005
BARD CONFORMEXX BILIARY STENT WITH THE PERFORMAXX GRIP
K052114 · FGE
Bard Peripheral Vascular, Inc.
Gastroenterology & Urology · 21d
Cleared Aug 24, 2005
MODIFICATION TO: LIFESTENT VALEO BILIARY STENT SYSTEM
K052132 · FGE
Edwards Lifesciences, LLC
Gastroenterology & Urology · 19d
Cleared Aug 24, 2005
SPYGLASS DIRECT VISUALIZATION PROBE AND OCULAR
K052194 · ODF
Boston Scientific Corp
Gastroenterology & Urology · 13d
Cleared Aug 23, 2005
FORMULA 418 BILIARY STENT
K051785 · FGE
Cook, Inc.
Gastroenterology & Urology · 53d
Cleared Aug 22, 2005
NORMOCARD 25 (STERILE BICARBONATE RENAL DIALYSIS CONCENTRATE)
K050827 · KPO
Dialysis Solutions, Inc.
Gastroenterology & Urology · 143d
Cleared Aug 18, 2005
COLONIC AND ENEMA NOZZLE
K051344 · KPL
Ultimate Concepts, Inc.
Gastroenterology & Urology · 87d
Cleared Aug 16, 2005
ACMI AUTOCLAVABLE URETEROSCOPE, MODELS MR-6A AND MR-6AL
K052044 · FGB
Acmi Corporation
Gastroenterology & Urology · 19d