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

    OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES

    K Number: K945267 · Decision May 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    10
    Review Days
    207

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    Basic Information

    Device Name
    OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K Number
    K945267
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    888.1100
    Medical Specialty
    Orthopedic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optus, Inc.
    Date Received
    October 28, 1994
    Decision Date
    May 23, 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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    Other Clearances by Optus, Inc.

    K Number Device Name
    K945264 OPTUS OTOSCOPES
    K953913 OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    K945268 OPTUS BRONCHOSCOPES
    K945265 OPTUS HYSTEROSCOPES AND CONTACT HYSTEROSCOPES
    K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
    K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K944656 OPTUS SINUSCOPES AND ACCESSORIES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES