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

    EasyMark Tissue Marker

    K Number: K183503 · Decision Oct 17, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    102
    Registration Numbers
    102
    Same Product Code
    109
    Applicant Total
    4
    Review Days
    304

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    Basic Information

    Device Name
    EasyMark Tissue Marker
    K Number
    K183503
    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
    Inrad, Inc.
    Date Received
    December 17, 2018
    Decision Date
    October 17, 2019
    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 Inrad, Inc.

    K Number Device Name
    K243886 ExpressCore Biopsy Device
    K240429 Trilogy Tissue Marker
    K112945 ELITECORE FULL CORE BIOPSY DEVICE 18GAX10CM, 18GAX15CM, 18GAX20, WITH/HILITIER 18GAX10CM , W/HILITER 18GAX15CM