BEUDAMED
    FDA 510(k) FDA class 1 Unknown 🇺🇸 United States

    GLAUCOMA COMPANION

    K Number: DEN140022 · Decision Apr 20, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    642

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    Basic Information

    Device Name
    GLAUCOMA COMPANION
    K Number
    DEN140022
    Device Class
    FDA class 1
    Clearance Type
    Direct
    Regulation Number
    886.5838
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Innovatex, Inc.
    Date Received
    July 18, 2014
    Decision Date
    April 20, 2016
    Product Code
    PLX
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PLX Tear Duct Occluder