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

    COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4

    K Number: K082051 · Decision Oct 16, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    50
    Registration Numbers
    50
    Same Product Code
    36
    Applicant Total
    6
    Review Days
    90

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    Basic Information

    Device Name
    COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4
    K Number
    K082051
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4400
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cosman Medical, Inc.
    Date Received
    July 18, 2008
    Decision Date
    October 16, 2008
    Product Code
    GXD
    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
    GXD Generator, Lesion, Radiofrequency

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    Other Clearances by Cosman Medical, Inc.

    K Number Device Name
    K101131 FIDUCIAL MARKERS
    K082012 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN
    K060799 COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA
    K053415 LESIONPOINT RF CANNULA
    K050084 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;