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510(k) Data Aggregation

    K Number
    K203586
    Device Name
    EndoSerter-PL
    Manufacturer
    Date Cleared
    2022-02-02

    (421 days)

    Product Code
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    CorneaGen, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EndoSerter® PL is used to insert corneal endothelial allograft tissue measuring less than or equal to 8.0 mm in diameter and 100 microns in central thickness into the anterior chamber through a minimum 4.0 mm incision during endothelial keratoplasty procedures and for loading and storage of donor transport to the surgeon by trained eye bank technicians, and for storage of donor tissue for up to a maximum of 48 hours.
    Device Description
    The EndoSerter®-PL is a sterile, single use, handheld, manual ophthalmic surgical instrument. It is used to preload a processed donor corneal endothelial allograft for storage and transportation to the ophthalmic surgeon and to deliver the allograft into the anterior chamber of the eye during corneal surgery. It is designed to deliver a corneal endothelial allograft into the eye during corneal endothelial keratoplasty. The loading and storage of donor tissue for transport to the surgeon is performed by trained technician at the eye bank.
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