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

    ViziShot 2 FLEX

    K Number: K163469 · Decision Apr 6, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    64
    Registration Numbers
    64
    Same Product Code
    32
    Applicant Total
    12
    Review Days
    115

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    Basic Information

    Device Name
    ViziShot 2 FLEX
    K Number
    K163469
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Surgical Technologies America
    Date Received
    December 12, 2016
    Decision Date
    April 6, 2017
    Product Code
    KTI
    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
    KTI Bronchoscope Accessory

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