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

    GIBSON ENDOLYMPHATIC SHUNT

    K Number: K897049 · Decision Mar 16, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    19
    Review Days
    88

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    Basic Information

    Device Name
    GIBSON ENDOLYMPHATIC SHUNT
    K Number
    K897049
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3820
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Applicant
    Hood Laboratories
    Date Received
    December 18, 1989
    Decision Date
    March 16, 1990
    Product Code
    ESZ
    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
    ESZ Tube, Shunt, Endolymphatic

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