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

    COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN

    K Number: K082012 · Decision Oct 14, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    91

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    Basic Information

    Device Name
    COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
    K Number
    K082012
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosman Medical, Inc.
    Date Received
    July 15, 2008
    Decision Date
    October 14, 2008
    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 Cosman Medical, Inc.

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    K053415 LESIONPOINT RF CANNULA
    K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;