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

    OMNI CYSTOSCOPE

    K Number: K922320 · Decision Jan 13, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    136
    Registration Numbers
    136
    Same Product Code
    91
    Applicant Total
    4
    Review Days
    240

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    Basic Information

    Device Name
    OMNI CYSTOSCOPE
    K Number
    K922320
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Expanded Optics, Inc.
    Date Received
    May 18, 1992
    Decision Date
    January 13, 1993
    Product Code
    FAJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FAJ Cystoscope And Accessories, Flexible/Rigid

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    Other Clearances by Expanded Optics, Inc.

    K Number Device Name
    K922321 OMNI ARTHROSCOPE
    K922319 OMNI LAPAROSCOPE
    K894570 UNIVERSAL LIGHT CABLE