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510(k) Data Aggregation

    K Number
    K162445
    Device Name
    LiVac Retractor System
    Manufacturer
    Date Cleared
    2016-10-20

    (50 days)

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

    Livac Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LiVac Retractor is designed as an organ and tissue retractor for use in laparoscopic procedures to elevate organs and tissue to provide improved access and visualisation of surgical sites.
    Device Description
    The LiVac Retractor System is a soft silicone ring connected to suction tubing and is designed to maintain apposition between two substantially planar, conformable, solid organ surfaces, most typically the diaphragm and either lobe of liver, or spleen, thereby exposing the organs beneath. The system is comprised of three components: 1.) LiVac Retractor, 2.) LiVac Bevel, and 3.) LiVac Connector. The suction tubing is connected to a sterile suction hose via the connector, which is positioned partially within the abdominal wall. The LiVac Connector can lie alongside a 12-15mm port within the secondary channel of the LiVac Bevel as per Hasson technique, or within a single incision laparoscopic port device.
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