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

    BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets

    K Number: K223243 · Decision Dec 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    134
    Review Days
    57

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    Basic Information

    Device Name
    BD Microtainer® Contact-Activated Lancets; BD Microtainer® Quikheel™ Lancets
    K Number
    K223243
    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
    Becton, Dickinson and Company
    Date Received
    October 20, 2022
    Decision Date
    December 16, 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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