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

    OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)

    K Number: K962952 · Decision Nov 29, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12
    Same Product Code
    6
    Applicant Total
    4
    Review Days
    122

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    Basic Information

    Device Name
    OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)
    K Number
    K962952
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical, Co.
    Date Received
    July 30, 1996
    Decision Date
    November 29, 1996
    Product Code
    LBK
    Advisory Committee
    Unknown
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LBK Neurosurgical Ultrasonic Instruments

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    Other Clearances by Olympus Optical, Co.

    K Number Device Name
    K990687 HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, ENDOSCOPIC CLIPS
    K982610 OLYMPUS UM-2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY EQUIPMENT (URINARY TRACT)
    K971340 OLYMPUS NEURO ENDOSCOPE