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

    1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE

    K Number: K950705 · Decision May 9, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    23
    Review Days
    83

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    Basic Information

    Device Name
    1.2MM DISPOSABLE NEUROVIEW PREFORMED ENDOSCOPE
    K Number
    K950705
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Neuro Navigational Corp.
    Date Received
    February 15, 1995
    Decision Date
    May 9, 1995
    Product Code
    HRX
    Advisory Committee
    Orthopedic
    Review Advisory Committee
    OR
    Third Party
    N

    Classifications

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

    Product Code Device Name
    HRX Arthroscope

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    K961173 1.2MM REUSABLE NEUROVIEW ENDOSCOPE
    K961300 ASPIRATION/IRRIGATION CATHETER
    K960792 DISPOSABLE NEUROVIEW INTRODUCER SHEATH
    K954938 DISPOSABLE NEUROVIEW OPERATING SHEATH
    K955351 NEUROVIEW COAXIAL BIPOLAR ELECTRODE
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    K955467 NEUROVIEW COAXIAL BIPOLAR ELECTRODE
    K955037 RIGID NEUROVIEW ENDOSCOPE
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