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
4057–4080 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 09, 2001
BOSS-2000-2 VACUUM ERECTION DEVICE
K012672 · LKY
Pos-T-Vac, Inc.
Gastroenterology & Urology · 88d
Cleared Nov 09, 2001
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE
K012951 · FGB
Circon Video
Gastroenterology & Urology · 66d
Cleared Nov 07, 2001
BODY FAT ANALYZER, MODEL HBF-306
K011652 · MNW
Omron Healthcare, Inc.
Gastroenterology & Urology · 162d
Cleared Nov 07, 2001
REPROCESSED ENDOSCOPIC TROCAR
K012578 · NLM
Sterilmed, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 07, 2001
DUR-8, MODELS DUR-8
K012925 · FGB
Circon Video
Gastroenterology & Urology · 68d
Cleared Nov 02, 2001
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · KNT
Zevex, Inc.
Gastroenterology & Urology · 115d
Cleared Nov 02, 2001
VARICES INJECTION NEEDLE
K012977 · FBK
Endo-Therapeutics, Inc.
Gastroenterology & Urology · 58d
Cleared Nov 01, 2001
DIACLEAR ULTRAFILTER
K003957 · FIP
Gambro Renal Products
Gastroenterology & Urology · 315d
Cleared Oct 31, 2001
PRISMA HF 1000 SET, PRISMA HF 1000 PRE-SET
K011221 · KDI
Gambro Renal Products
Gastroenterology & Urology · 194d
Cleared Oct 31, 2001
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40...
K011916 · MSD
Horizon Medical Products, Inc.
Gastroenterology & Urology · 133d
Cleared Oct 26, 2001
GYNECARE TENSION-FREE VAGINAL TAPE SYSTEM
K012628 · OTN
Gynecare Center
Gastroenterology & Urology · 74d
Cleared Oct 26, 2001
SPARC SLING SYSTEM
K013355 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 16d
Cleared Oct 24, 2001
MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY...
K012822 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 62d
Cleared Oct 24, 2001
INTERJECT INJECTION THERAPY NEEDLE, MODELS 1810, 1811, 1815, 1816, 1820,...
K012864 · FCG
Boston Scientific Corp
Gastroenterology & Urology · 58d
Cleared Oct 19, 2001
MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM
K012510 · KDI
Nxstage Medical, Inc.
Gastroenterology & Urology · 74d
Cleared Oct 19, 2001
DUAL PORT WIZARD LOW PROFILE REPLACEMENT GASTROSTOMY DEVICE
K013144 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
AUTOTOME RX MODEL # 4515, 4516
K013153 · KNS
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
MARK II/MARK III MANOMETRIC PERFUSION PUMP
K013154 · FFX
Dentsleeve Pty., Ltd.
Gastroenterology & Urology · 29d
Cleared Oct 19, 2001
14F X 24CM ASH SPLIT-CATH,14F X 28CM ASH SPLIT-CATH, 14F X 32CM ASH...
K013162 · KNT
Medcomp
Gastroenterology & Urology · 28d
Cleared Oct 19, 2001
WILSON-COOK ULTRASOUND BIOPSY NEEDLE
K013356 · FCG
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 9d
Cleared Oct 17, 2001
METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088
K012265 · FCW
Circon Video
Gastroenterology & Urology · 90d
Cleared Oct 16, 2001
STORZ MODULITH SLK LITHOTRIPTER WITH MULTIVIEW OPTION
K012482 · LNS
KARL STORZ Endoscopy-America, Inc.
Gastroenterology & Urology · 75d
Cleared Oct 15, 2001
TORAYSULFONE DIALYZER
K002512 · KDI
Toray Industries (America), Inc.
Gastroenterology & Urology · 426d
Cleared Oct 15, 2001
CHIBA NEEDLE
K012358 · FCG
Ispg, Inc.
Gastroenterology & Urology · 82d