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

    OLYMPUS NEURO ENDOSCOPE

    K Number: K971340 · Decision Jul 29, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    65
    Registration Numbers
    65
    Same Product Code
    92
    Applicant Total
    4
    Review Days
    475

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    Basic Information

    Device Name
    OLYMPUS NEURO ENDOSCOPE
    K Number
    K971340
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.1480
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympus Optical, Co.
    Date Received
    April 10, 1997
    Decision Date
    July 29, 1998
    Product Code
    GWG
    Advisory Committee
    Neurology
    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
    GWG Endoscope, Neurological

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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)
    K962952 OLYMPUS ULTRASONIC SURGICAL SYSTEM (USU)