BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SYMMETRY KERRISON DISPOSABLE TIP RONGEURS

    K Number: K130541 · Decision Aug 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    61
    Registration Numbers
    61
    Same Product Code
    35
    Applicant Total
    2
    Review Days
    157

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    Basic Information

    Device Name
    SYMMETRY KERRISON DISPOSABLE TIP RONGEURS
    K Number
    K130541
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4840
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Symmetry Surgical
    Date Received
    March 1, 2013
    Decision Date
    August 5, 2013
    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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