BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇮🇪 Ireland

    Zilver 518 Biliary Stent, Zilver 635 Biliary Stent

    K Number: K182980 · Decision Nov 16, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    143
    Registration Numbers
    143
    Same Product Code
    473
    Applicant Total
    32
    Review Days
    18

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    Basic Information

    Device Name
    Zilver 518 Biliary Stent, Zilver 635 Biliary Stent
    K Number
    K182980
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5010
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Cook Ireland, Ltd.
    Date Received
    October 29, 2018
    Decision Date
    November 16, 2018
    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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