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

    NURO NEUROMODULATION SYSTEM

    K Number: K132561 · Decision Nov 5, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    7
    Applicant Total
    1
    Review Days
    82

    Basic Information

    Device Name
    NURO NEUROMODULATION SYSTEM
    K Number
    K132561
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5310
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    ADVANCED URO-SOLUTIONS, INC.
    Date Received
    August 15, 2013
    Decision Date
    November 5, 2013
    Product Code
    NAM
    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
    NAM Stimulator, Peripheral Nerve, Non-Implanted, For Urinary Incontinence

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