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510(k) Data Aggregation

    K Number
    K191545
    Device Name
    Exogenesis Hernia Mesh
    Date Cleared
    2019-09-26

    (107 days)

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

    Exogenesis Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Exogenesis Hernia Mesh is indicated for the repar of abdominal wall hernias and abdominal wall deficiencies that require the addition of reinforcing material to obtain the desired surgical result. The Exogenesis Hernia Mesh is indicated for the repair of abdominal wall hernia defects, including inguinal (direct & indirect). The Exogenesis Hernia Mesh is not indicated for transvaginal pelvic organ prolapse repair. The Exogenesis Hernia Mesh is intended for single patient one-time use only.
    Device Description
    The Exogenesis Hernia Mesh is a sterile prosthesis designed to provide mechanical support for reconstruction of soft tissue deficiencies. The device is intended for the repair of hernias and other fascial deficiencies requiring the addition of reinforcing or bridging material to obtain the desired surgical result. The Exogenesis Hernia Mesh is composed of knitted filaments of extruded polypropylene, and knitted to provide elasticity in both directions. This construction permits the mesh to be cut into any desired shape or size without unraveling. The Exogenesis Hernia Mesh is treated with a proprietary technology to modify the surface of the mesh to increase surface area of the filaments on a microscopic level.
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