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

    Illuminated Mediastinal Access Port

    K Number: K160171 · Decision Feb 26, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    10
    Applicant Total
    2
    Review Days
    30

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    Basic Information

    Device Name
    Illuminated Mediastinal Access Port
    K Number
    K160171
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4720
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aegis Surgical, Ltd.
    Date Received
    January 27, 2016
    Decision Date
    February 26, 2016
    Product Code
    EWY
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    EWY Mediastinoscope, Surgical

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