BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇳 China

    Disposable Double Lumen Endobronchial Tube

    K Number: K232529 · Decision May 13, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    33
    Applicant Total
    3
    Review Days
    266

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    Basic Information

    Device Name
    Disposable Double Lumen Endobronchial Tube
    K Number
    K232529
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5740
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shenzhen Insighters Medical Technology Co., Ltd.
    Date Received
    August 21, 2023
    Decision Date
    May 13, 2024
    Product Code
    CBI
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CBI Tube, Tracheal/Bronchial, Differential Ventilation (W/Wo Connector)

    Similar 510(k) Clearances

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    Endobronchial Blocker Tube (EBT0109); Endobronchial Blocker Tube (EBT0107); Endobronchial Blocker Tube (EBT0105); Endobronchial Blocker Tube (EBT0109S); Endobronchial Blocker Tube (EBT0107S); Endobronchial Blocker Tube (EBT0105S); Endobronchial Blocker Tube (EBT0209); Endobronchial Blocker Tube (EBT0207); Endobronchial Blocker Tube (EBT0205); Endobronchial Blocker Tube (EBT0209S); Endobronchial Blocker Tube (EBT0207S); Endobronchial Blocker Tube (EBT0205S)

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    Other Clearances by Shenzhen Insighters Medical Technology Co., Ltd.

    K Number Device Name
    K242793 Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.
    K232580 Disposable Endobronchial Blocker Tube