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

    Facet 28G Universal Lancet

    K Number: K221433 · Decision Jul 15, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    82
    Registration Numbers
    82
    Same Product Code
    15
    Applicant Total
    7
    Review Days
    59

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    Basic Information

    Device Name
    Facet 28G Universal Lancet
    K Number
    K221433
    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
    Facet Technologies, LLC
    Date Received
    May 17, 2022
    Decision Date
    July 15, 2022
    Product Code
    QRK
    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
    QRK Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature

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    Other Clearances by Facet Technologies, LLC

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