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

    OLYMPUS ULTRASONIC SURGICAL SYSTEM

    K Number: K031523 · Decision Oct 1, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    115
    Registration Numbers
    116
    Same Product Code
    156
    Applicant Total
    7
    Review Days
    139

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    Basic Information

    Device Name
    OLYMPUS ULTRASONIC SURGICAL SYSTEM
    K Number
    K031523
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aomori Olympus Co., Ltd.
    Date Received
    May 15, 2003
    Decision Date
    October 1, 2003
    Product Code
    LFL
    Advisory Committee
    Unknown
    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
    LFL Instrument, Ultrasonic Surgical

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    Other Clearances by Aomori Olympus Co., Ltd.

    K Number Device Name
    K042160 SONOSURG TROCAR
    K041566 SONOSURG ULTRASONIC SURGICAL SYSTEM
    K033333 SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B
    K031710 OLYMPUS ULTRASONIC SURGICAL SYSTEM
    K021672 PANCREATIC DRAINAGE TUBE
    K022446 MUCUS COLLECTION PROBE, MODELS BC-401C & BC-402C