BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇪 Germany

    Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs

    K Number: K150468 · Decision Feb 29, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    371

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    Basic Information

    Device Name
    Laminectomy Rongeurs, Kerrison Rongeurs, IVD Rongeurs
    K Number
    K150468
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    K2 Medical GmbH & Co. KG
    Date Received
    February 23, 2015
    Decision Date
    February 29, 2016
    Product Code
    HAE
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HAE Rongeur, Manual

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