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510(k) Data Aggregation

    K Number
    K163002
    Device Name
    Kangaroo Feeding Tube with IRIS Technology
    Date Cleared
    2017-05-16

    (200 days)

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

    Covidien (dba Medtronic)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Kangaroo™ Feeding Tube with IRIS Technology utilizes a video stream to aid a trained user during placement into the stomach or small bowels for the administration of nutrition, fluids, and medications by the naso-enteric route for patients aged 18 years and older who have an intact gastrointestinal tract, but are physically unable to manage nutritional intake through normal mastication and deglutition. Prior to commencing administration, confirm correct tube placement per institutional protocol. Placement of the tip of the device into the small bowel should only be attempted by clinicians with expertise in small bowel placement.
    Device Description
    The Kangaroo™ Feeding Tube with IRIS Technology is a small-bore nasogastric enteral access catheter. The gastrointestinal tube includes an external proximal access port for connection to enteral feeding sets and to syringes with ENFit connector. The tubing is constructed with a radiopaque material and with a hydrophilic coating to assist with insertion of the tube. The stylet is made of specially designed metal wire, which may be utilized to assist with tube placement. The tube is equipped with external markings in units of centimeters to assist in estimating the length of tube inserted into the alimentary tract. The device may be connected to a console, which allows for viewing a video stream and capture of camera images an interface cable connects the feeding tube to the console. LED light is incorporated into the distal tip of the tube and the light will power on only when properly connected to the console with the interface cable.
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