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

    OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES

    K Number: K953913 · Decision Jan 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    386
    Registration Numbers
    386
    Same Product Code
    680
    Applicant Total
    10
    Review Days
    154

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    Basic Information

    Device Name
    OPTUS ARTHROSCOPE & MINI-ARTHROSCOPE ACCESSORIES
    K Number
    K953913
    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
    August 21, 1995
    Decision Date
    January 22, 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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    Other Clearances by Optus, Inc.

    K Number Device Name
    K945264 OPTUS OTOSCOPES
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    K945262 OPTUS CYSTOSCOPES AND PEDIATRIC CYSTOSCOPES
    K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K945266 OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K944656 OPTUS SINUSCOPES AND ACCESSORIES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES