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510(k) Data Aggregation

    K Number
    K090677
    Device Name
    INNOPORT LAPAROSCOPIC ACCESS DEVICE
    Manufacturer
    INNOVIA LLC
    Date Cleared
    2009-05-07

    (52 days)

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

    INNOVIA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Innovia InnoPort™ Laparoscopic Access Port is a sterile, single use device, intended for use as a multiple instrument and/or camera port during minimally invasive laparoscopic abdominal surgery.
    Device Description
    The InnoPort™ Laparoscopic Access Port is a sterile, single use laparoscopic access device made of a flexible Quatromer polymer combined with polycarbonate and polyurethane components. It forms a truncated cone approximately 5.0 centimeters long (not including instrument ports), with three individual laparoscopic instrument ports at the larger end. A fourth port connects to the insufflation system to provide intra-abdominal pneumoperitoneum. The instrument ports are designed to accommodate 5 mm diameter laparoscopic instruments while allowing full maneuverability without loss of pneumoperitoneum. The complete device is designed to be inserted through a single incision into the abdominal cavity for the duration of surgery.
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