BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇹 Austria

    ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)

    K Number: K222214 · Decision Oct 17, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    24
    Registration Numbers
    24
    Same Product Code
    12
    Applicant Total
    2
    Review Days
    449

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    Basic Information

    Device Name
    ViVi® Surgical Helmet System (ViVi® Helmet, ViVi® Helmet HPL, ViVi® Hood)
    K Number
    K222214
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4040
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Thi Total Healthcare Innovation GmbH
    Date Received
    July 25, 2022
    Decision Date
    October 17, 2023
    Product Code
    FXY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXY Hood, Surgical

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    Other Clearances by Thi Total Healthcare Innovation GmbH

    K Number Device Name
    K243522 ViVi® Toga Premium