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

    RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE

    K Number: K032054 · Decision Sep 15, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    250
    Registration Numbers
    250
    Same Product Code
    422
    Applicant Total
    8
    Review Days
    75

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    Basic Information

    Device Name
    RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
    K Number
    K032054
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4560
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radionics, A Division of Tyco Healthcare Group LP
    Date Received
    July 2, 2003
    Decision Date
    September 15, 2003
    Product Code
    HAW
    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
    HAW Neurological Stereotaxic Instrument

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