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

    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412

    K Number: K040018 · Decision Jan 20, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    432
    Review Days
    14

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    Basic Information

    Device Name
    EXCELON TRANSBRONCHIAL ASPIRATION NEEDLE, MODELS 6410, 6411, 6412
    K Number
    K040018
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Boston Scientific Corp
    Date Received
    January 6, 2004
    Decision Date
    January 20, 2004
    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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