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510(k) Data Aggregation

    K Number
    K102999
    Device Name
    TRIMOTION INJECTOR
    Manufacturer
    Date Cleared
    2011-12-29

    (447 days)

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

    KANEKA CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kaneka Trimotion™ Injector is indicated for insertion and placement of donor corneal tissue (diameter: ≤ 8.5 mm; thickness: 0.115-0.200 mm) into the anterior chamber of the recipient eye through a minimum 5.5 mm incision during a Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure.
    Device Description
    The Kaneka Trimotion™ Injector is a single-use pen-shaped injector made of stainless steel and biocompatible plastics. It is used to fold, insert, and place donor corneal tissue by means of a major surgical procedure into a human eye during the Descemet's Stripping with Automated Endothelial Keratoplasty (DSAEK) procedure. Two color-coded sliding controls, called "pushers", are used to control the delivery of the donor tissue. Irrigation with intraocular irrigating solution and an air injection are applied through the device to aid in tissue delivery and placement. The system provides a tubular pathway through an incision posterior to the cornea limbus, allowing delivery of the donor tissue into the human eye.
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