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

    Accu-Chek Safe-T-Pro Uno Lancing Device

    K Number: K220364 · Decision Apr 5, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    153
    Registration Numbers
    153
    Same Product Code
    105
    Applicant Total
    6
    Review Days
    56

    Basic Information

    Device Name
    Accu-Chek Safe-T-Pro Uno Lancing Device
    K Number
    K220364
    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
    Roche Diabetes Care, Inc.
    Date Received
    February 8, 2022
    Decision Date
    April 5, 2022
    Product Code
    FMK
    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
    FMK Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature

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