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

    AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE

    K Number: K860891 · Decision Apr 21, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    1
    Review Days
    42

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    Basic Information

    Device Name
    AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE
    K Number
    K860891
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Intra-Optics Labs. C/O Newman Assoc.
    Date Received
    March 10, 1986
    Decision Date
    April 21, 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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