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
2473–2496 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 28, 2011
PALINDROME H, SI, HSI CHRONIC CATHETER
K112477 · NYU
Covidien
Gastroenterology & Urology · 30d
Cleared Sep 19, 2011
NXSTAGE PUREFLOW SL
K111174 · FKR
Nxstage Medical, Inc.
Gastroenterology & Urology · 145d
Cleared Sep 14, 2011
EXPECT ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
K112198 · ODG
Boston Scientific Corporation
Gastroenterology & Urology · 44d
Cleared Sep 09, 2011
UNIMAX ANTI-FOG SOLUTION
K111622 · OCT
Unimax Medical Systems, Inc.
Gastroenterology & Urology · 91d
Cleared Sep 08, 2011
PREFILLED CATHETER INFLATION SYRINGE
K112209 · KNY
Avail Medical Products, Inc.
Gastroenterology & Urology · 38d
Cleared Sep 06, 2011
FULL CORE BIOPSY SYSTEM
K111765 · KNW
Promex Technologies, LLC
Gastroenterology & Urology · 75d
Cleared Aug 30, 2011
PALINDROME RT CHRONIC CATHETER
K111817 · MSD
Covidien
Gastroenterology & Urology · 64d
Cleared Aug 26, 2011
COMFORTGLIDE INTERMITENT CATHETER
K112137 · EZD
C.R. Bard, Inc.
Gastroenterology & Urology · 31d
Cleared Aug 23, 2011
DEKA TAC DEVICE
K093915 · FIG
Deka Research & Development Corp.
Gastroenterology & Urology · 609d
Cleared Aug 19, 2011
INBODY
K110689 · MNW
Biospace Corporation Limited
Gastroenterology & Urology · 157d
Cleared Aug 19, 2011
VITALA CONTINENCE CONTROL DEVICE
K111365 · EZQ
Convatec, Inc.
Gastroenterology & Urology · 95d
Cleared Aug 17, 2011
NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER
K111900 · MSD
Teleflexmedical, Inc.
Gastroenterology & Urology · 43d
Cleared Aug 09, 2011
NAVIAID(TM) BGC DEVICE
K111760 · ODC
Smart Medical Systems , Ltd.
Gastroenterology & Urology · 48d
Cleared Aug 04, 2011
SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE
K110005 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 213d
Cleared Aug 04, 2011
TAL PALLINDROME (TM) SYMMETRIC TIP DUAL LUMEN CATHETER, MAHURKAR (R) MAXID...
K111372 · MSD
Covidien
Gastroenterology & Urology · 80d
Cleared Aug 01, 2011
CURE CATHETER
K110653 · EZD
Cure Medical, LLC
Gastroenterology & Urology · 147d
Cleared Aug 01, 2011
SONOLITH I-MOVE
K111808 · LNS
Edap Tms France
Gastroenterology & Urology · 35d
Cleared Jul 29, 2011
VOYAGER PERITONEAL DIALYSIS SYSTEM
K103220 · FKX
Deka Research & Development Corp.
Gastroenterology & Urology · 270d
Cleared Jul 29, 2011
MAGNUM CORE TISSUE BIOPSY NEEDLE MODEL MN1820, RP CUTTING NEEDLE MODEL...
K111529 · KNW
Insert Molding Solutions, Inc.
Gastroenterology & Urology · 57d
Cleared Jul 29, 2011
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
K111611 · ESW
Merit Medical Systems, Inc.
Gastroenterology & Urology · 50d
Cleared Jul 28, 2011
BIOPSY VALVE
K111821 · OCX
Endochoice, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 27, 2011
TISSUE SAMPLING NEEDLE
K103694 · FCG
United States Endoscopy Group, Inc.
Gastroenterology & Urology · 222d
Cleared Jul 22, 2011
ENDOFLIP GASTRIC TUBE
K110529 · KNT
Crospon, Ltd.
Gastroenterology & Urology · 148d
Cleared Jul 19, 2011
COOK GI ENDOSCOPIC INJECTION GEL KIT, GEL-S, GEL-N, GEL-H, GEL-K
K111495 · FBK
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 49d