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

    BABYLANCE HEEL INCISION DEVICE

    K Number: K130132 · Decision Feb 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    157
    Registration Numbers
    157
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    24

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    Basic Information

    Device Name
    BABYLANCE HEEL INCISION DEVICE
    K Number
    K130132
    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
    Medipurpose Pte. , Ltd.
    Date Received
    January 18, 2013
    Decision Date
    February 11, 2013
    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
    K222224 SurgiLance® Safety Lancet
    K110062 MEDIPLUS-FOAM AG; MEDIPLUS-COMFORTFOAM AG; MEDIPLUS-SUPERFOAM AG
    K101145 SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250
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