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

    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)

    K Number: K260420 · Decision Apr 8, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    6
    Review Days
    58

    Basic Information

    Device Name
    LoopView® Single-Use Digital Flexible Bronchoscope (B27-C, B27-CG)
    K Number
    K260420
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    MacroLux Medical Technology Co., Ltd.
    Date Received
    February 9, 2026
    Decision Date
    April 8, 2026
    Product Code
    EOQ
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    EOQ Bronchoscope (Flexible Or Rigid)

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    Other Clearances by MacroLux Medical Technology Co., Ltd.

    K Number Device Name
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