BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    LumiRex Bronchoscope

    K Number: K243541 · Decision Apr 30, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    2
    Review Days
    166

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    Basic Information

    Device Name
    LumiRex Bronchoscope
    K Number
    K243541
    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
    Contra Healthcare Solutions, LLC
    Date Received
    November 15, 2024
    Decision Date
    April 30, 2025
    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 Contra Healthcare Solutions, LLC

    K Number Device Name
    K243532 LumiRex Ureteroscope