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

    NERVE CUFF

    K Number: K132660 · Decision Jan 10, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    37
    Registration Numbers
    37
    Same Product Code
    39
    Applicant Total
    16
    Review Days
    137

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    Basic Information

    Device Name
    NERVE CUFF
    K Number
    K132660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5275
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cook Biotech Incorporated
    Date Received
    August 26, 2013
    Decision Date
    January 10, 2014
    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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