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

    TRUEdraw Lancing Device, Mini Lancing Device

    K Number: K221072 · Decision Oct 18, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    84
    Registration Numbers
    84
    Same Product Code
    23
    Applicant Total
    1
    Review Days
    189

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    Basic Information

    Device Name
    TRUEdraw Lancing Device, Mini Lancing Device
    K Number
    K221072
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Trividia Health
    Date Received
    April 12, 2022
    Decision Date
    October 18, 2022
    Product Code
    QRL
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only

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