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

    DISPOSABLE VITRECTOMY PROBE

    K Number: K970673 · Decision May 5, 1997
    View on FDA
    Classifications
    1
    FEI Numbers
    36
    Registration Numbers
    36
    Same Product Code
    148
    Applicant Total
    2
    Review Days
    70

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    Basic Information

    Device Name
    DISPOSABLE VITRECTOMY PROBE
    K Number
    K970673
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.4150
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Altex Vision
    Date Received
    February 24, 1997
    Decision Date
    May 5, 1997
    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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    Other Clearances by Altex Vision

    K Number Device Name
    K970670 REUSABLE VITRECTOMY PROBE