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510(k) Data Aggregation

    K Number
    K212407
    Device Name
    Gastric Lightguide (GLG)
    Date Cleared
    2022-07-26

    (357 days)

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

    Naser Dib Gabinet Lekarksi Nasmed

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Use in gastric and bariatric surgical procedures for the application of suction, stomach decompression and drainage of gastric fluids and irrigation.
    Device Description
    The GLG (Gastric Light Guide) is a multi-channel bougie which allows all functions to be performed with one device and one insertion. The GLG is a single use device that is provided sterile (sterilized using Ethylene Oxide). A light channel runs the full length of the bougie, illuminating the oral cavity and pharynx for proper insertion. The GLG connects to a battery powered light handle that are 510(k) exempt under product codes FSW and HJM. The GLG transilluminates the anterior stomach wall while suction holds it in place, highlighting the shape of the bougie and allowing the surgeon to see the best path for stapling. The GLG is inserted at the beginning of the procedure and not removed until after the leak test. The GLG is composed of a double lumen tube composed of medical grade PVC with holes and an atraumatic tip. There is a blue connector for use with standard suction equipment 36 Fr. The light wire is a 3mm diameter wire composed of PMMA with several cut-outs. The light wire does not make patient contact. There is a black connector 10 Fr for the light wire to be connected to a reusable light handle, battery operated LED light source. There is only one model available GLG001, size 36 Fr and 1000mm in length with a closed lightwire channel. The GLG devices are packaged in paper/film packages of material suitable for ethylene oxide sterilization. The units are sold in carton boxes which contain 6 intermediate boxes of 5 units of GLG each.
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