BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MINIGUARD

    K Number: K954215 · Decision May 8, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    9
    Review Days
    243

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    Basic Information

    Device Name
    MINIGUARD
    K Number
    K954215
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5160
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Surgical Intervention, Inc.
    Date Received
    September 8, 1995
    Decision Date
    May 8, 1996
    Product Code
    MNG
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Expedited Review
    Y
    Third Party
    N

    Classifications

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

    Product Code Device Name
    MNG External Urethral Occluder, Urinary Incontinence-Control, Female

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