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510(k) Data Aggregation

    K Number
    K071764
    Device Name
    REALIZE GASTRIC CALIBRATION TUBE, MODELS GCT180, GCT360
    Manufacturer
    OBTECH MEDICAL SARL
    Date Cleared
    2007-10-24

    (117 days)

    Product Code
    KNT
    Regulation Number
    876.5980
    Why did this record match?
    Applicant Name (Manufacturer) :

    OBTECH MEDICAL SARL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The gastric calibration tube is indicated for use in gastric and bariatric surgical procedures to provide visible and tactile delineation of the antrum of the stomach along with the ability to decompress the stomach, drain and remove gastric fluid and size a gastric pouch.
    Device Description
    The REALIZETM Gastric Calibration Tube is a non-sterile, single patient use instrument consisting of a 745 mm long silicone tube with an approximate 38 F (12.7mm) rounded, closed tip. At the proximal end, the tube is equipped with a check valve which mates with a syringe used to fill a balloon located approximately 6.8 cm from the distal tip. At the distal end, the tube has two suction/irrigation holes that allow the removal of fluids and/ or irrigation during the procedure, if necessary. Reference markings are provided on the tube shaft, with the zero reference located approximately 39.6 cm from the proximal end of the balloon.
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