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510(k) Data Aggregation
K Number
K073164Device Name
IVS TUNNELLER DEVICES
Manufacturer
Date Cleared
2008-03-05
(117 days)
Product Code
Regulation Number
878.3300Why 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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