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

    GENERAL AND PLASTIC SURGERY

    K Number: K140835 · Decision May 20, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    6
    Review Days
    48

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    Basic Information

    Device Name
    GENERAL AND PLASTIC SURGERY
    K Number
    K140835
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Scion Medical Technologies, LLC
    Date Received
    April 2, 2014
    Decision Date
    May 20, 2014
    Product Code
    NEU
    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
    NEU Marker, Radiographic, Implantable

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    Other Clearances by Scion Medical Technologies, LLC

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    K170905 Star Tissue Marker
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