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

    OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES

    K Number: K945266 · Decision Feb 23, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    10
    Review Days
    118

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    Basic Information

    Device Name
    OPTUS LAPAROSCOPES AND OPERATING LAPAROSCOPES
    K Number
    K945266
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Optus, Inc.
    Date Received
    October 28, 1994
    Decision Date
    February 23, 1995
    Product Code
    GCJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GCJ Laparoscope, General & Plastic Surgery

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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
    K945267 OPTUS ARTHROSCOPES AND MINI-ARTHROSCOPES
    K944656 OPTUS SINUSCOPES AND ACCESSORIES
    K945263 OPTUS THORACOSCOPES
    K945269 OPTUS LARYNGOSCOPES