BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    NervAlign Nerve Cuff

    K Number: K202234 · Decision Feb 10, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    39
    Applicant Total
    1
    Review Days
    552

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    Basic Information

    Device Name
    NervAlign Nerve Cuff
    K Number
    K202234
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renerve, Ltd.
    Date Received
    August 7, 2020
    Decision Date
    February 10, 2022
    Product Code
    JXI
    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
    JXI Cuff, Nerve

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