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510(k) Data Aggregation

    K Number
    K200968
    Device Name
    ABC33L, ABC35L, ABC37L, ABC39L, ABC33R, ABC35R, ABC37R, ABC39R
    Manufacturer
    INSUNG MEDICAL CO., LTD.
    Date Cleared
    2020-12-28

    (262 days)

    Product Code
    CBI
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSUNG MEDICAL CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This device is intended for use in thoracic surgery, bronchospirometry, administration of Endobronchial anesthesia and other uses commonly requiring Endobronchial intubation. The Endobronchial tube is indicated for main stem bronchus intubation and allows for selective inflation or deflation of either lung.
    Device Description
    ANKOR Endobronchial tube is consisted with double lumen tube with the body including 3 cuff (Bronchus Cuff, Trachea Cuff and ANKOR Cuff) / 2 cuff (Bronchus Cuff and Trachea Cuff), the stylet and elbow connector in order to separate connector for isolating and ventilating one lung during surgical procedures. The different point, between ABC Model and HBC Model, is whether ANKOR Cuff is consisted. ANKOR Cuff, which is a part of the ABC Model only, takes to check correct insertion of the catheter. When user is lack of the experience or is not confidence with operation, ABC Model is intended to use. When the suction is necessary, this device can be possible to be assemble with suction catheter which is 10Fr or 12Fr with PVC (Listing Number: D422226) and this device is packaged with these suction catheter (Listing Number: D422226). The device is made of silicone as a main material and is available in 33Fr to 39Fr depending on the patients who is requiring one-lung isolation under OR and ICU including Non-MR Environment only.
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