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

    VES-10 INTRAOCULAR SCISSORS DRIVE

    K Number: K864035 · Decision Dec 15, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    8
    Review Days
    60

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    Basic Information

    Device Name
    VES-10 INTRAOCULAR SCISSORS DRIVE
    K Number
    K864035
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Trek Medical Products, Inc.
    Date Received
    October 16, 1986
    Decision Date
    December 15, 1986
    Product Code
    HQE
    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
    HQE Instrument, Vitreous Aspiration And Cutting, Ac-Powered

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