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
4105–4128 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Sep 06, 2001
JMS A.V. FISTULA NEEDLE SET ACCORDION TYPE
K002352 · FIE
Jms Co., Ltd.
Gastroenterology & Urology · 400d
Cleared Sep 06, 2001
UROSCOPE, ARTES MEDICAL, USA
K003988 · FAJ
Artes Medical USA, Inc.
Gastroenterology & Urology · 254d
Cleared Aug 31, 2001
DORNIER LITHOTRIPTER S(DOLI S) & DORNIER LITHOTRIPTER S-XP (DOLI S-XP)
K011873 · LNS
Dornier
Gastroenterology & Urology · 77d
Cleared Aug 31, 2001
MONARCH, TRANSSHAPING GASTROSTOMY TUBE MODEL 9-2010
K012476 · KNT
Applied Medical Technology, Inc.
Gastroenterology & Urology · 29d
Cleared Aug 27, 2001
PALMAZ GENESIS TRANSHEPATIC BILLARY STENT AND DELIVERY SYSTEM
K010411 · FGE
Cordis Corp.
Gastroenterology & Urology · 196d
Cleared Aug 24, 2001
VAXCEL DIALYSIS CATHETER
K012365 · MSD
Boston Scientific Corp
Gastroenterology & Urology · 29d
Cleared Aug 24, 2001
EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
K012445 · FFK
Electro Medical Systems SA
Gastroenterology & Urology · 23d
Cleared Aug 23, 2001
RADIUS NEXT GENERATION GUIDEWIRE
K011759 · OCY
Radius Medical Technologies, Inc.
Gastroenterology & Urology · 78d
Cleared Aug 23, 2001
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K012347 · FGE
Sulzer Intratherapeutics, Inc.
Gastroenterology & Urology · 30d
Cleared Aug 23, 2001
MODIFICATION TO: LOFRIC PLUS SINGLE USE URINARY CATHETER
K012374 · GBM
Astra Tech, Inc.
Gastroenterology & Urology · 28d
Cleared Aug 22, 2001
BRIDGE FX
K011817 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 72d
Cleared Aug 22, 2001
SINGLE ACTION BIOPSY NEEDLE, MODEL RCBS: XX GAUGE, XX LENGTH, XX THROW
K012224 · KNW
Ranfac, Corp.
Gastroenterology & Urology · 67d
Cleared Aug 17, 2001
SPEEDYBELL
K010735 · KNW
Biopsybell S.A.S.
Gastroenterology & Urology · 158d
Cleared Aug 17, 2001
22MM SITESELECT BREAST BIOPSY DEVICE MODEL SSD022
K011575 · KNW
Imagyn Surgical
Gastroenterology & Urology · 87d
Cleared Aug 17, 2001
NIROYAL BILIARY PREMOUNTED STENT SYSTEM
K012216 · FGE
Boston Scientific Scimed, Inc.
Gastroenterology & Urology · 32d
Cleared Aug 16, 2001
HORIZONS INTERNATIONAL POLYPECTOMY SNARES
K011667 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 78d
Cleared Aug 16, 2001
FRESENIUS ARTERIAL BLOODLINE SETS FOR HEMODIALYSIS, FRESENIUS COMBI SETS...
K012242 · FJK
Fresenius Medical Care North America
Gastroenterology & Urology · 30d
Cleared Aug 14, 2001
DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC,...
K010399 · MSD
Diatek, Inc.
Gastroenterology & Urology · 186d
Cleared Aug 13, 2001
COOK ZILVER BILIARY STENT
K010242 · FGE
Cook, Inc.
Gastroenterology & Urology · 200d
Cleared Aug 13, 2001
INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS
K011184 · FGE
Intratherapeutics, Inc.
Gastroenterology & Urology · 117d
Cleared Aug 10, 2001
ROSS EMBRACE PUMP SET
K011467 · KNT
Ross Products
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
POLYGRAM 98 ANORECTAL FUNCTION TESTING APPLICATION, POLYGRAM 98 ESOPHAGEAL...
K011472 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-9-1
K011484 · FBK
Olympus Optical Co., Ltd.
Gastroenterology & Urology · 88d
Cleared Aug 10, 2001
CYSTO-URETHROSCOPES E-LINE EXISTING OF: SHEATHS, OBTURATORS, INSERTS,...
K011496 · FBO
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 87d