BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    TD-5010 Lancing Device and TD-5084 Sterile Lancets

    K Number: K221419 · Decision Jan 20, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    77
    Registration Numbers
    77
    Same Product Code
    22
    Applicant Total
    2
    Review Days
    249

    Basic Information

    Device Name
    TD-5010 Lancing Device and TD-5084 Sterile Lancets
    K Number
    K221419
    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
    GOSTAR Co., Ltd.
    Date Received
    May 16, 2022
    Decision Date
    January 20, 2023
    Product Code
    QRL
    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
    QRL Multiple Use Blood Lancet For Single Patient Use Only

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    Other Clearances by GOSTAR Co., Ltd.

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