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

    Single Use Biopsy Forceps FB-456D

    K Number: K200397 · Decision Apr 24, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    226
    Applicant Total
    60
    Review Days
    66

    Basic Information

    Device Name
    Single Use Biopsy Forceps FB-456D
    K Number
    K200397
    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
    Olympus Medical Systems Corp.
    Date Received
    February 18, 2020
    Decision Date
    April 24, 2020
    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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    K221660 RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE-XP
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