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

    COOLIEF Cooled Radiofrequency Kit Advanced

    K Number: K203066 · Decision Dec 22, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    85
    Registration Numbers
    85
    Same Product Code
    62
    Applicant Total
    7
    Review Days
    74

    Basic Information

    Device Name
    COOLIEF Cooled Radiofrequency Kit Advanced
    K Number
    K203066
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.4725
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Avanos Medical, Inc.
    Date Received
    October 9, 2020
    Decision Date
    December 22, 2020
    Product Code
    GXI
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    Y

    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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