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

    Barrigel Injectable Gel

    K Number: K220641 · Decision May 26, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    5
    Applicant Total
    1
    Review Days
    83

    Basic Information

    Device Name
    Barrigel Injectable Gel
    K Number
    K220641
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.5725
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Palette Life Sciences
    Date Received
    March 4, 2022
    Decision Date
    May 26, 2022
    Product Code
    OVB
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    OVB Hydrogel Spacer

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