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

    Sentimag System

    K Number: K222832 · Decision Jan 21, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    5
    Review Days
    123

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    Basic Information

    Device Name
    Sentimag System
    K Number
    K222832
    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
    September 20, 2022
    Decision Date
    January 21, 2023
    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 Endomagnetics Ltd.,

    K Number Device Name
    K232865 Magseed Pro Magnetic Marker System
    K173587 Magseed Magnetic Marker Systtem
    K163541 Magseed Magnetic Marker System
    K153044 Sentimag System, Sentimark Magnetic Marker Systerm