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

    Tenderfoot

    K Number: K223352 · Decision Mar 2, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    3
    Review Days
    120

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    Basic Information

    Device Name
    Tenderfoot
    K Number
    K223352
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Accriva Diagnostics, Inc.
    Date Received
    November 2, 2022
    Decision Date
    March 2, 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 Accriva Diagnostics, Inc.

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    K193041 Hemochron Signature Elite