BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Sentimag System, Sentimark Magnetic Marker Systerm

    K Number: K153044 · Decision Mar 2, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    6
    Applicant Total
    5
    Review Days
    135

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    Basic Information

    Device Name
    Sentimag System, Sentimark Magnetic Marker Systerm
    K Number
    K153044
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4300
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Endomagnetics Ltd.,
    Date Received
    October 19, 2015
    Decision Date
    March 2, 2016
    Product Code
    PBY
    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
    PBY Temporary Tissue Marker

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    Other Clearances by Endomagnetics Ltd.,

    K Number Device Name
    K232865 Magseed Pro Magnetic Marker System
    K222832 Sentimag System
    K173587 Magseed Magnetic Marker Systtem
    K163541 Magseed Magnetic Marker System