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

    RADIONICS POLE NEEDLES

    K Number: K021942 · Decision Sep 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    8
    Review Days
    90

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    Basic Information

    Device Name
    RADIONICS POLE NEEDLES
    K Number
    K021942
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Radionics, A Division of Tyco Healthcare Group LP
    Date Received
    June 13, 2002
    Decision Date
    September 11, 2002
    Product Code
    GXI
    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
    GXI Probe, Radiofrequency Lesion

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    Other Clearances by Radionics, A Division of Tyco Healthcare Group LP

    K Number Device Name
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    K032054 RADIONICS NASHOLD BIOPSY NEEDLE - SINGLE USE
    K023519 RADIONICS VARILINK 2
    K013661 XPLAN 2.2 WITH THE BODY SYSTEM
    K012850 RECORDING AND STIMULATING ELECTRODE
    K010548 MODIFICATION TO OPTICAL TRACKING SYSTEM (OTS)