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
3841–3864 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Nov 25, 2002
LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE
K022686 · FED
Lap Surgical Systems, LLC
Gastroenterology & Urology · 104d
Cleared Nov 21, 2002
POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151
K014269 · MYE
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 329d
Cleared Nov 19, 2002
MONARC SLING SYSTEM
K023516 · OTN
American Medical Systems, Inc.
Gastroenterology & Urology · 29d
Cleared Nov 18, 2002
RENAX HEMODIALYSIS BLOOD TUBING SET
K014140 · FJK
Sunder Biomedical Tech. Co., Ltd.
Gastroenterology & Urology · 336d
Cleared Nov 18, 2002
BAXTER ACCURA SYSTEM, MODEL 5M5660
K021615 · KDI
Baxter Healthcare Corp
Gastroenterology & Urology · 186d
Cleared Nov 13, 2002
FRESENIUS ICARE MONITORING SYSTEM
K021060 · FKP
Fresenius Medical Care North America
Gastroenterology & Urology · 225d
Cleared Nov 08, 2002
BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER...
K011471 · FFX
Medtronic Functional Diagnostics A/S
Gastroenterology & Urology · 543d
Cleared Nov 06, 2002
RETRO REPAIR KIT, MODEL PRRK5
K022644 · NFK
Spire Biomedical, Inc.
Gastroenterology & Urology · 90d
Cleared Nov 06, 2002
INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE
K023344 · KNT
Bowel Management Systems, LLC
Gastroenterology & Urology · 30d
Cleared Nov 04, 2002
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION
K021732 · KDI
Dideco S.P.A.
Gastroenterology & Urology · 164d
Cleared Nov 04, 2002
REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS
K022751 · KGE
Medical Device Services
Gastroenterology & Urology · 77d
Cleared Nov 01, 2002
PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS
K011005 · FIP
Pure Water Solutions, Inc.
Gastroenterology & Urology · 576d
Cleared Oct 31, 2002
MEDCOMP REPAIR KIT, MODEL ASPCRPK
K022570 · NFK
Medcomp
Gastroenterology & Urology · 90d
Cleared Oct 30, 2002
\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW...
K022536 · KOC
Fresenius Medical Care
Gastroenterology & Urology · 90d
Cleared Oct 25, 2002
BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM
K021630 · FGE
Boston Scientific Corp
Gastroenterology & Urology · 161d
Cleared Oct 25, 2002
HORIZONS REUSABLE HOT BIOPSY FORCEPS
K022243 · KGE
Horizons Intl. Corp.
Gastroenterology & Urology · 105d
Cleared Oct 25, 2002
HORIZONS REUSABLE POLYPECTOMY SNARES
K022268 · FDI
Horizons Intl. Corp.
Gastroenterology & Urology · 102d
Cleared Oct 25, 2002
COOK INJECTION NEEDLE
K022484 · FBK
Cook Urological, Inc.
Gastroenterology & Urology · 88d
Cleared Oct 25, 2002
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K023217 · FGE
Cordis Corp.
Gastroenterology & Urology · 29d
Cleared Oct 25, 2002
INFUSION CATHETER EXTENSION SET
K023224 · KDI
Chf Solutions, Inc.
Gastroenterology & Urology · 28d
Cleared Oct 21, 2002
DIASOL-ADDITIVES
K020231 · KPO
Diasol, Inc.
Gastroenterology & Urology · 271d
Cleared Oct 21, 2002
MODIFICATION TO KPS-1, KIDNEY PERFUSION SOLUTIION
K022391 · KDN
Organ Recovery Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Oct 21, 2002
NXSTAGE PREMIXED DIALYSATE
K022913 · KPO
Nxstage Medical, Inc.
Gastroenterology & Urology · 48d
Cleared Oct 17, 2002
PORGES SILICONE DOUBLE LOOP URETERAL STENT, MODEL # AJ4X / BJ1X / BJ2X
K013921 · FAD
Porges S.A.
Gastroenterology & Urology · 324d