LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    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) .
    Ask a Question

    Page 1 of 1