BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    Broncoflex Agile, Broncoflex Vortex, Screeni

    K Number: K212886 · Decision Feb 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    2
    Review Days
    159

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    Basic Information

    Device Name
    Broncoflex Agile, Broncoflex Vortex, Screeni
    K Number
    K212886
    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
    Axess Vision Technology
    Date Received
    September 10, 2021
    Decision Date
    February 16, 2022
    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 Axess Vision Technology

    K Number Device Name
    K202180 Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001