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510(k) Data Aggregation

    K Number
    K222919
    Device Name
    GORE® ENFORM Biomaterial
    Manufacturer
    W. L. Gore and Associates, Inc.
    Date Cleared
    2022-12-19

    (84 days)

    Product Code
    OXF, OWT, OWZ, OXC
    Regulation Number
    878.3300
    Why did this record match?
    Applicant Name (Manufacturer) :

    W. L. Gore and Associates, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    GORE® ENFORM Biomaterial is indicated for use in the reinforcement of soft tissue. This includes use in patients requiring soft tissue reinforcement in plastic and reconstructive surgery. Examples of applications where GORE® ENFORM Biomaterial may be used include hernia repair as suture-line reinforcement, muscle flap reinforcement, and general tissue reconstructions.
    Device Description
    As packaged, GORE® ENFORM Biomaterial is a porous, three-dimensional sheet comprised of a bioabsorbable PGA:TMC copolymer in a matrix (scaffold) structure that functions to reinforce soft tissue during the phases of wound healing by filling soft-tissue deficits. The bioabsorbable, porous scaffold structure of the ENFORM device elicits a physiological response which fills the deficit with native tissue and gradually absorbs the device. There are two configurations of the GORE® ENFORM Biomaterial. One configuration will possess an added PGA:TMC film layer on one side of the device to provide visceral protection in soft tissue reinforcement applications requiring intraperitoneal contact with the viscera. Both ENFORM configurations are available in various sizes and can be trimmed to the desired shape by the surgeon at time of use. The GORE® ENFORM Biomaterial is supplied sterile for single use only.
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