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

    ORTHO CONTROL FEMALE URINARY CONTROL DEVICE

    K Number: K010365 · Decision Apr 30, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    6
    Applicant Total
    45
    Review Days
    82

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    Basic Information

    Device Name
    ORTHO CONTROL FEMALE URINARY CONTROL DEVICE
    K Number
    K010365
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5160
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Personal Products Co.
    Date Received
    February 7, 2001
    Decision Date
    April 30, 2001
    Product Code
    MNG
    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
    MNG External Urethral Occluder, Urinary Incontinence-Control, Female

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