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    K Number
    K182434
    Device Name
    LaparoGuard
    Manufacturer
    Mariner Endosurgery Inc.
    Date Cleared
    2018-12-13

    (98 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mariner Endosurgery Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    LaparoGuard is indicated for use with compatible laparoscopic devices. LaparoGuard can be used in general laparoscopy wherever a laparoscope is indicated for use.
    Device Description
    LaparoGuard allows surgeons to virtually annotate a safe anatomical volume ("safe zone") inside the body cavity of a patient during a laparoscopic surgery. A compatible laparoscope, such as the ConMed IM3300 (K031098), captures video feed that is processed by LaparoGuard, which tracks surgical instruments and the safe zone boundaries to display a real-time overlay on a compatible laparoscope monitor, such as the Stryker Vision Elect 21" (K081995). Surgical teams receive visual and auditory notifications throughout the procedure whenever a tracked instrument has exited the safe zone.
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