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

    THE GRIESHABER AXIAL CUTTER

    K Number: K950056 · Decision May 5, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    15
    Applicant Total
    15
    Review Days
    119

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    Basic Information

    Device Name
    THE GRIESHABER AXIAL CUTTER
    K Number
    K950056
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Grieshaber & Co.
    Date Received
    January 6, 1995
    Decision Date
    May 5, 1995
    Product Code
    HKP
    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
    HKP Instrument, Vitreous Aspiration And Cutting, Battery-Powered

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