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

    EXPRESS MINI GLAUCOMA SHUNT

    K Number: K030350 · Decision Mar 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    24
    Applicant Total
    2
    Review Days
    38

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    Basic Information

    Device Name
    EXPRESS MINI GLAUCOMA SHUNT
    K Number
    K030350
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    886.3920
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Optonol, Ltd.
    Date Received
    February 3, 2003
    Decision Date
    March 13, 2003
    Product Code
    KYF
    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
    KYF Implant, Eye Valve

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    Other Clearances by Optonol, Ltd.

    K Number Device Name
    K012852 EX-PRESS MINATURE GLAUCOMA IMPLANT, MODELS R-20, R-30, R-50, STS VERSIONS