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

    ENDO OPTIKS VALUE PACK

    K Number: K923600 · Decision Mar 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    159
    Registration Numbers
    159
    Same Product Code
    109
    Applicant Total
    2
    Review Days
    246

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    Basic Information

    Device Name
    ENDO OPTIKS VALUE PACK
    K Number
    K923600
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4370
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Statement
    Applicant
    Endo Optics, Inc.
    Date Received
    July 20, 1992
    Decision Date
    March 23, 1993
    Product Code
    LRO
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LRO General Surgery Tray

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    Other Clearances by Endo Optics, Inc.

    K Number Device Name
    K924090 THE ENDO OPTIKS MICROPROBE