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    K Number
    K042132
    Device Name
    NOVASYS TRANSURETHRAL RF SYSTEM
    Manufacturer
    NOVASYS MEDICAL, INC.
    Date Cleared
    2004-12-21

    (134 days)

    Product Code
    NVJ
    Regulation Number
    878.4400
    Why did this record match?
    Product Code :

    NVJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Novasys Transurethral RF System is indicated for the transurethral treatment of female stress urinary incontinence due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
    Device Description
    The Novasys Transurethral RF Generator delivers controlled, low-level radiofrequency energy through the Novasys Transurethral RF Probe for localized collagen denaturation.
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