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

    M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM

    K Number: K944309 · Decision Apr 3, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    548
    Registration Numbers
    548
    Same Product Code
    1422
    Applicant Total
    2
    Review Days
    213

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    Basic Information

    Device Name
    M.E.R. SURGICAL CO. OMNI INSTRUMENT SYSTEM
    K Number
    K944309
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    M.E.R. Surgical Co.
    Date Received
    September 2, 1994
    Decision Date
    April 3, 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 M.E.R. Surgical Co.

    K Number Device Name
    K951424 M. E. R. SURGICAL CO. OMIN INSTRUMENT SYSTEM