BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇯🇵 Japan

    FUJIFILM Video Bronchoscopes

    K Number: K182253 · Decision Apr 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    64
    Review Days
    227

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    Basic Information

    Device Name
    FUJIFILM Video Bronchoscopes
    K Number
    K182253
    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
    Fujifilm Corporation
    Date Received
    August 20, 2018
    Decision Date
    April 4, 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 Fujifilm Corporation

    K Number Device Name
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    K251861 FUJIFILM Endoscope Model ED-S100TP; FUJIFILM Endoscope Model ED-S100XP; FUJIFILM Processor Model VS-1000
    K250550 FUJIFILM Endoscope Model EG-S100XT and VS-1000 Display Unit
    K253568 Hood DH-084STR; Hood DH-094STR; Hood DH-104STR; Hood DH-114STR; Hood DH-124STR; Hood DH-134STR
    K250863 FUJIFILM Ultrasonic Endoscope EB-710US
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    K244017 FUJIFILM Endoscope Model EB-710P; FUJIFILM Processor EP-8000
    Search all 64 clearances from Fujifilm Corporation →