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

    Kerrison Rongeurs

    K Number: K152734 · Decision Jun 18, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    1
    Review Days
    270

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    Basic Information

    Device Name
    Kerrison Rongeurs
    K Number
    K152734
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vitalitec Medizintechnik GmbH
    Date Received
    September 22, 2015
    Decision Date
    June 18, 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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