FDA.reportPublic FDA data

510(k) K012724

Device
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273
Applicant
Smith & Nephew, Inc.
510(k) number
K012724
Product code
LYK
Decision
Substantially Equivalent (SESE)
Decision date
2001-11-08
Date received
2001-08-14
Regulation
876.1500
Classification name
Angioscope
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
JANICE HASELTON
Address
160 Dascomb Rd. Andover MA US 01810 01810

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LYK#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253842Vena MicroAngioscope™ SystemVena Medical Holdings Corp2026-01-28
K251767Vena MicroAngioscope™ SystemVena Medical Holdings Corp2025-10-01
K062340CARDIOOPTICS AUGMENTATIVE CARDIAC OPTICAL IMAGING SYSTEMCardio-Optics, Inc.2006-11-30
K050808CORONARY SINUS ACCESS KIT, MODEL KCS8F-01Cardio-Optics, Inc.2005-07-28
K011793KSEA FIBERSCOPEKARL STORZ Endoscopy-America, Inc.2002-04-17
K001408KSEA VASCULAR FIBERSCOPESKARL STORZ Endoscopy-America, Inc.2000-10-30
K964061GORE ANGIOSCOPIC VALVVLOTOME KIT (TBD)W. L. Gore & Associates, Inc.1997-02-20
K9526384.5F IMAGECATH CORONARY ANGIOSCOPE, MODEL COV45 [SUBSEQUENTLY REFERRED TO AS THE MODIFIED ANGIOSCOPE[Baxter Edwards1995-07-28
K951721APPLIED MEDICAL 1.5MM REUSABLE ANGIOSCOPEApplied Medical Resources1995-07-11
K945591APPLIED MEDICAL OPTICAL VALVULOTOMEApplied Medical Resources1995-02-10
K941715ULTATHIN FLEXIBLE ENDOSCOPETechnology Marketing Group1994-10-04
K934696ANGIOSCOPEIntramed Laboratories, Inc.1994-01-18
K931464BAXTER CORONARY ANGIOSCOPE INFLATION DEVICEBaxter Healthcare Corp1993-10-18
K930758DIAGNOSTIC INTRAVASCULAR CATHETERApplied Medical Resources1993-09-24
K931421DISPOSABLE STEERABLE ANGIOSCOPEEndovascular, Inc.1993-06-16