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

    ARTHOSCOPE

    K Number: K960805 · Decision Apr 10, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    368
    Registration Numbers
    368
    Same Product Code
    669
    Applicant Total
    218
    Review Days
    42

    Basic Information

    Device Name
    ARTHOSCOPE
    K Number
    K960805
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC
    Date Received
    February 28, 1996
    Decision Date
    April 10, 1996
    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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