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510(k) Data Aggregation

    K Number
    K073164
    Device Name
    IVS TUNNELLER DEVICES
    Date Cleared
    2008-03-05

    (117 days)

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

    COVIDIEN UK MANUFACTURING LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI), mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency, and vaginal vault prolapse. The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is intended to be used in females to position a polypropylene mesh for the treatment of genuine stress urinary incontinence (SUI) and for mixed incontinence resulting from urethral hypermobility or intrinsic sphincter deficiency.
    Device Description
    The IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile. The Obturator IVS Tunneller™ Intra-Vaginal Sling placement device is comprised of three components: a stainless steel introducer or outer sheath, a polypropylene stylette, and a polypropylene mesh tape. The introducer is a curved stainless steel tube with a delta wing polypropylene handle, which is used to create a pathway for the correct placement of the polypropylene mesh tape. The polypropylene stylette has an eyelet for threading the polypropylene mesh tape and an atraumatic conical tip which allows for blunt tissue dissection and muscle deflection during the passage of the introducer. The polypropylene mesh tape is a non-absorbable, inert, porous, surgical mesh tape, created from either monofilament or multifilament yarns, and is supplied sterile.
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