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

    SURELITE AND SURELITE XL BLOOD LANCET

    K Number: K902416 · Decision Aug 1, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    13
    Review Days
    62

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    Basic Information

    Device Name
    SURELITE AND SURELITE XL BLOOD LANCET
    K Number
    K902416
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4850
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Gainor Medical Europe, Ltd.
    Date Received
    May 31, 1990
    Decision Date
    August 1, 1990
    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 Gainor Medical Europe, Ltd.

    K Number Device Name
    K926448 I.V. ADMINISTRATION SET
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    K922441 SURESEAL BANDAGE
    K913333 I.V. PRIMING SET
    K902422 NEEDLE, ASPIRATION & INJECTION, DISPOSABLE
    K902420 CATHETER, NASAL, OXYGEN
    K902564 NEEDLE, DIALYSIS
    K902426 HEMODIALYSIS SYSTEM AND ACCESSORY
    K902421 STOMACH, GASTRO-ENTEROSTOMY
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