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510(k) Data Aggregation

    K Number
    K223074
    Device Name
    CorNeat EverPatch
    Manufacturer
    CorNeat Vision Ltd.
    Date Cleared
    2023-06-02

    (245 days)

    Product Code
    QWU
    Regulation Number
    886.3130
    Why did this record match?
    Applicant Name (Manufacturer) :

    CorNeat Vision Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CorNeat EverPatch is intended for implantation to reinforce sclera and aid the physical reconstruction of the ocular surface.
    Device Description
    The CorNeat EverPatch is a synthetic, tissue-integrating surgical matrix made of non-degradable polymer fibers. The EverPatch includes 6 bio-stitching holes which are intended to anchor the device by facilitating direct conjunctival adhesion to the sclera thus supporting its bio-integration. The holes at each corner can also be used to suture the device to the sclera.
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