BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

    GlideScope BFlex 5.8 Single-Use Bronchoscope

    K Number: K191948 · Decision Aug 21, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    6
    Review Days
    30

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    Basic Information

    Device Name
    GlideScope BFlex 5.8 Single-Use Bronchoscope
    K Number
    K191948
    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
    Verathon Medical (Canada) Ulc
    Date Received
    July 22, 2019
    Decision Date
    August 21, 2019
    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 Verathon Medical (Canada) Ulc

    K Number Device Name
    K253696 CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)
    K230948 BFlex™ 2 Slim 3.8 Single-Use Bronchoscope
    K211947 GlideScope BFlex 2.8 Single-Use Bronchoscope
    K193488 GlideScope BFlex 3.8 Single-Use Bronchoscope
    K183256 GlideScope BFlex Single-Use Bronchoscope System