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510(k) Data Aggregation
K Number
K191545Device Name
Exogenesis Hernia Mesh
Manufacturer
Date Cleared
2019-09-26
(107 days)
Product Code
Regulation Number
878.3300Why 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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