BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    NIR BILIARY STENT

    K Number: K973171 · Decision Nov 13, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    6
    Review Days
    445

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    Basic Information

    Device Name
    NIR BILIARY STENT
    K Number
    K973171
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Medinol, Ltd.
    Date Received
    August 25, 1997
    Decision Date
    November 13, 1998
    Product Code
    FGE
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FGE Stents, Drains And Dilators For The Biliary Ducts

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    Other Clearances by Medinol, Ltd.

    K Number Device Name
    K173581 Gallant PTCA Dilatation Catheter
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    K150487 X-Suit NIR Biliary Metallic Stent
    K081956 MEDINOL X-SUIT NIR BILIARY METALLIC STENT
    K002130 NIR BILIARY STENT