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

    URASSIST

    K Number: K062061 · Decision Oct 5, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    40
    Registration Numbers
    40
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    77

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    Basic Information

    Device Name
    URASSIST
    K Number
    K062061
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    876.5250
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Preferred Medical Devices, Inc.
    Date Received
    July 20, 2006
    Decision Date
    October 5, 2006
    Product Code
    NZU
    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
    NZU Collector, Urine, Powered, Non Indwelling Catheter