BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit

    K Number: K222643 · Decision Oct 19, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    3
    Review Days
    48

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    Basic Information

    Device Name
    Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    K Number
    K222643
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Sirius Medical Systems B.V.
    Date Received
    September 1, 2022
    Decision Date
    October 19, 2022
    Product Code
    PBY
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    PBY Temporary Tissue Marker

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    Other Clearances by Sirius Medical Systems B.V.

    K Number Device Name
    K223682 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit
    K200734 Sirius Pintuition Seed, Sirius Pintuition Probe, Sirius Pintuition Base Unit