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

    ANCHORAGE SCOPE, MODEL 000003

    K Number: K080780 · Decision Jul 30, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    18
    Applicant Total
    3
    Review Days
    133

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    Basic Information

    Device Name
    ANCHORAGE SCOPE, MODEL 000003
    K Number
    K080780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Epitek, Inc.
    Date Received
    March 19, 2008
    Decision Date
    July 30, 2008
    Product Code
    FBO
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FBO Cystourethroscope

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    Other Clearances by Epitek, Inc.

    K Number Device Name
    K073507 ANCHORAGE ACCESS KIT
    K073096 ANCHORAGE CLOSURE DEVICE