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510(k) Data Aggregation

    K Number
    K242536
    Device Name
    TauTona Pneumoperitoneum Assist Device (TPAD)
    Manufacturer
    TauTona Group
    Date Cleared
    2024-10-15

    (50 days)

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

    TauTona Group

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TauTona Pneumoperitoneum Assist Device (TPAD) is intended for use with the 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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    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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    K Number
    K131963
    Device Name
    TAUTONA INJECTOR DEVICE
    Manufacturer
    TAUTONA GROUP, LLC
    Date Cleared
    2013-10-22

    (117 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Why did this record match?
    Applicant Name (Manufacturer) :

    TAUTONA GROUP, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TauTona Injector Device is a syringe assist device and is intended for use in the administration of sterile materials / autologous adipose tissue under aseptic conditions in accordance with the best judgment of the clinician. The TauTona Injector Device is intended for use with standard syringes / cannulas.
    Device Description
    The TauTona Injector (TTI) Device is a hand-held, sterile, single-use, disposable device and is designed to be used with, off-the-shelf syringes and injection cannulas. The device is used to assist the physician in injection fluids into the body. The clinician connects the TTI device to the pre-filled syringe and a standard re-injection cannula (Size 9, 14G). The device is activated by a trigger mechanism that enables fluid delivery in specific aliquot sizes. The TTI Device is a simple handle that consists of the following components: - . Pump with an enclosed motor - Battery pack (12V) . - . Controller (printed circuit board with software) - . Dispensing trigger - . On/off/aliquot size select switch - . Indicator light - . Syringe luer connector (female) - Cannula luer connector (male) .
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