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510(k) Data Aggregation

    K Number
    K203350
    Device Name
    ENDOtube
    Date Cleared
    2021-09-29

    (320 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nissha Medical Technologies SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ENDOtube devices are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/ or air to an endoscope during gastrointestinal endoscopic procedure. These devices are intended to be used by healtheare professional only. In procedure room, all ENDOtube devices are 24 hours use disposable products except the one-way valves which are single use products and the insufflation connectors which are multiple patient use.
    Device Description
    The ENDOtube kits are a combination of tubes, fittings and valves intended to provide sterile water and/or CO2 and/or air to an endoscope during a GI endoscopic procedure. The ENDOtube products are compatible with various endoscopes (FujiFilm® 500/600 series and 700 series, OLYMPUS® 140, 160, 180 and 190 and PENTAX®), and irrigation pumps (OLYMPUS®, Erbe® and EMED®). The ENDOtube products include several families: ENDOtube for Wash Bottle, ENDOtube for Insufflation, ENDOtube for Wash Pump, and ENDOtube for Wash Bottle CO2 Insufflation.
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