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    K Number
    K240185
    Device Name
    Cypris eXact Suture Placement Device
    Manufacturer
    Cypris Medical
    Date Cleared
    2024-05-03

    (101 days)

    Product Code
    GEJ
    Regulation Number
    878.4800
    Why did this record match?
    Product Code :

    GEJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.
    Device Description
    The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.
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