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510(k) Data Aggregation

    K Number
    K233020
    Device Name
    TauTona Pneumoperitoneum Assist Device (TPAD)
    Manufacturer
    TauTona Group Research & Development, Co. LLC
    Date Cleared
    2024-01-12

    (112 days)

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

    **TauTona Group Research **& Development, Co

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use in the upper left quadrant of the abdominal wall (i.e., Palmer's Point) with a Veress needle for the establishment of a pneumoperitoneum during laparoscopic procedures.
    Device Description
    The TauTona Pneumoperitoneum Assist Device (TPAD) is a single use device used during laparoscopic surgical procedures. The device consists of a pad which contains an array of suction cups on one side; a port that attaches to a standard hospital vacuum line; a button to control vacuum to the suction cups; and a handle to allow user to manipulate the device. Suction is applied to the device to allow the user to manipulate (hold and pull on) the tissue around the Veress needle insertion site. The device is crescent in shape to allow removal of the device after use while the Veress needle remains in the patient.
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