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

    OMNI LAPAROSCOPE

    K Number: K922319 · Decision Apr 23, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    4
    Review Days
    340

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    Basic Information

    Device Name
    OMNI LAPAROSCOPE
    K Number
    K922319
    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
    April 23, 1993
    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 Expanded Optics, Inc.

    K Number Device Name
    K922321 OMNI ARTHROSCOPE
    K922320 OMNI CYSTOSCOPE
    K894570 UNIVERSAL LIGHT CABLE