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

    COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA

    K Number: K060799 · Decision May 2, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    65
    Applicant Total
    6
    Review Days
    39

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    Basic Information

    Device Name
    COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
    K Number
    K060799
    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
    March 24, 2006
    Decision Date
    May 2, 2006
    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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    K053415 LESIONPOINT RF CANNULA
    K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;