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510(k) Data Aggregation

    K Number
    K212786
    Device Name
    LevaLap Laparoscopic Access Device
    Date Cleared
    2022-02-23

    (175 days)

    Product Code
    Regulation Number
    884.1730
    Why did this record match?
    Applicant Name (Manufacturer) :

    Core Access Surgical Technologies, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LevaLap Laparoscopic Access Device is intended for use in the peri-umbilical region of the abdominal wall prior to the establishment of a pneumoperitoneum to aid in the insertion of a Veress needle during gynecologic (pelvic) and general surgical (intra-abdominal) laparoscopic procedures.
    Device Description
    The LevaLap Laparoscopic Access Device is a sterile single-use device, consisting of a clear hemisphere-shaped housing containing a port for connection to a standard operating room (OR) vacuum system and a septum for introduction of a Veress needle. The LevaLap Laparoscopic Access Device is intended to raise the abdominal wall above critical organs and vessels by means of negative pressure, thus creating an initial space prior to insufflation in preparation for laparoscopic access. The device includes a vacuum bypass plug positioned in the vacuum intake port.
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