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

    Accu-Chek Safe-T-Pro Uno Lancing Device

    K Number: K232509 · Decision Nov 13, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    9
    Review Days
    87

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    Basic Information

    Device Name
    Accu-Chek Safe-T-Pro Uno Lancing Device
    K Number
    K232509
    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
    August 18, 2023
    Decision Date
    November 13, 2023
    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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    Other Clearances by Roche Diabetes Care, Inc.

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