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510(k) Data Aggregation

    K Number
    K092207
    Device Name
    RESTORELLE POLYPROPYLENE MESH
    Manufacturer
    MPATHY MEDICAL DEVICES INC
    Date Cleared
    2009-08-04

    (13 days)

    Product Code
    OTP, OTO
    Regulation Number
    884.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    MPATHY MEDICAL DEVICES INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESTORELLE™ polypropylene mesh may be used for the repair of abdominal wall hernia, including inguinal, femoral, and incisional, and uterovaginal prolapse and other fascial deficiencies that require support material. It may be used in open or laparoscopic abdominal procedures or for repair by the vaginal route.
    Device Description
    Restorelle™ is a non-absorbable polypropylene mesh constructed from knitted monofilaments of extruded polypropylene. Restorelle™ polypropylene mesh is constructed using a warp-knit process to a unique design that permits the mesh to be cut into any desired shape or size without unraveling. It maintains excellent isotropic properties arising from its knitted construction. Restorelle™ polypropylene mesh has the necessary strength, flexibility, durability and surgical adaptability properties which permit the correct adaptation to the various stresses encountered in the body. The device is supplied sterile.
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