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510(k) Data Aggregation

    K Number
    K162110
    Device Name
    CORGRIP NG/NI Tube Retention System
    Manufacturer
    CORPAK MedSystems, Inc. a Division of Haylard Health
    Date Cleared
    2016-09-15

    (48 days)

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

    CORPAK MedSystems, Inc. a Division of Haylard Health

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CORGRIP Nasogastric/Nasointestinal (NGNI) Tube Retention System is indicated for use with enteral feeding tubes of 8 FR and greater and NG decompression, suction and drainage tubes up to 18 FR to prevent inadvertent removal or displacement of the tubes for adult patients.
    Device Description
    The CORGRIP NG/NI Tube Retention System is an accessary to prevent unwanted displacement or removal of nasogastric/nasojejunal tubes for adult patients by retaining the tube to the patient's nasal septum. The device consists of three main components: insertion (delivery) catheter, retrieval catheter, and tube clamp. The catheters are placed in either nare of the patient and the clinician maneuvers the catheters to connect the magnets at the back of the patient's nasal septum. Both catheters have a flexible tip to aid in magnet connection. Once connection is made the magnet on the insertion catheter is pulled through the nare by the retrieval catheter. Both catheters are then removed from each nare until the ends of the umbilical tape are exiting either nare. The umbilical tape is then secured to the feeding tube with the provided clamp. The proposed device adds the option of a 14, 16 and 18 Fr clamp.
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