BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇬 Singapore

    SurgiLance® Safety Lancet

    K Number: K222224 · Decision Sep 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    59

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    Basic Information

    Device Name
    SurgiLance® Safety Lancet
    K Number
    K222224
    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
    Medipurpose Pte. , Ltd.
    Date Received
    July 25, 2022
    Decision Date
    September 22, 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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    Other Clearances by Medipurpose Pte. , Ltd.

    K Number Device Name
    K130132 BABYLANCE HEEL INCISION DEVICE
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    K101145 SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
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