Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K023898
    Device Name
    GYNE IDEAS MINITAPE RP DEVICE
    Manufacturer
    GYNE IDEAS LTD.
    Date Cleared
    2003-06-18

    (208 days)

    Product Code
    PAH
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GYNE IDEAS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used as a pubourethral sling for the treatment of female urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
    Device Description
    The device consists of a polypropylene sling with integral serrated anchoring arms. The sling has an overall length of 14cm. It is supplied with two metal needles to aid in surgical placement of the device. The device is supplied sterile.
    Ask a Question

    Page 1 of 1