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
3889–3912 of 9,870
Search insights Median review: 88d Cleared: 100% Top manufacturer: C.R. Bard, Inc. Lead specialty: Gastroenterology & Urology
Cleared Aug 20, 2002
ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5
K021717 · GCT
World of Medicine Lemke GmbH
Gastroenterology & Urology · 89d
Cleared Aug 16, 2002
MODULITH SLK LITHOTRIPTER
K011700 · LNS
Karl Storz Endoscopy
Gastroenterology & Urology · 441d
Cleared Aug 15, 2002
KSEA QUADRO SWITCH
K021776 · OCX
Karl Storz Endoscopy
Gastroenterology & Urology · 78d
Cleared Aug 14, 2002
SINGLE STEP BIOPSY DEVICE, SINGLE STEP SURGICAL HANDLE, SINGLE STEP DRIVER,...
K021707 · KNW
Senorx, Inc.
Gastroenterology & Urology · 83d
Cleared Aug 14, 2002
SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K021898 · FGE
Cordis Corp.
Gastroenterology & Urology · 65d
Cleared Aug 12, 2002
TRANSONIC FLOW-QC SET MODEL ADT1010
K021571 · MQS
Transonic Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Aug 09, 2002
GIVEN DIAGNOSTICS SYSTEM
K022362 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 18d
Cleared Aug 08, 2002
URETERAL STENT
K013784 · FAD
Boston Scientific Corp
Gastroenterology & Urology · 267d
Cleared Aug 06, 2002
PRISMA SYSTEM
K010805 · KDI
Gambro Renal Products
Gastroenterology & Urology · 508d
Cleared Aug 05, 2002
MPW HEMODIALYSIS WATER PURIFICATION SYSTEM
K001755 · FIP
Mpw Industrial Water Services, Inc.
Gastroenterology & Urology · 787d
Cleared Aug 05, 2002
MEDIPLUS SINGLE USE GI MANOMETRY CATHETER
K013704 · KLA
Mediplus , Ltd.
Gastroenterology & Urology · 270d
Cleared Aug 05, 2002
BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U
K022434 · MND
C.R. Bard, Inc.
Gastroenterology & Urology · 11d
Cleared Aug 02, 2002
ENDOVIVE INITIAL PLACEMENT DIRECT PEJ KIT, ENDOVIVE STANDARD PROFILE BALLOON...
K020120 · KNT
Boston Scientific Corp
Gastroenterology & Urology · 200d
Cleared Aug 01, 2002
DAYTON WATER SYSTEMS ULTRAPURE WATER TREATMENT SYSTEMS FOR HEMODIALYSIS
K021352 · FIP
Dayton Water Systems
Gastroenterology & Urology · 94d
Cleared Jul 29, 2002
REPROCESSED TROCARS AND CANNULAS
K012644 · NLM
Surgical Instruments Service and...
Gastroenterology & Urology · 350d
Cleared Jul 26, 2002
FOSSA URETERAL STONE SWEEPER
K021602 · FAD
Fossa Industries, Inc.
Gastroenterology & Urology · 72d
Cleared Jul 25, 2002
CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES
K022169 · KNW
Parallax Medical, Inc.
Gastroenterology & Urology · 22d
Cleared Jul 24, 2002
PRISMAFLO
K020103 · KOC
Stihler Electronic GmbH
Gastroenterology & Urology · 194d
Cleared Jul 23, 2002
CRIT-LINE MONITOR III TQA (CLM TQA)
K011741 · FIL
Hemametrics
Gastroenterology & Urology · 413d
Cleared Jul 19, 2002
ESOPHAGEAL Z-STENT WITH DUA ANTI-REFLUX VALVE
K011591 · ESW
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 421d
Cleared Jul 19, 2002
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS...
K022000 · MSD
Spire Biomedical, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 19, 2002
MEDTRONIC AVE BRIDGE POLARIS BILIARY STENT SYSTEM (POLARIS)
K022026 · FGE
Medtronic Ave, Inc.
Gastroenterology & Urology · 28d
Cleared Jul 18, 2002
MAGNAFLOW MAGNETICALLY GUIDED ENTERAL FEEDING TUBE
K021991 · KNT
Syncro Medical Innovations, Inc.
Gastroenterology & Urology · 30d
Cleared Jul 16, 2002
INFANT FEEDING TUBES
K020005 · KNT
Promedic, Inc.
Gastroenterology & Urology · 195d