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

    Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology

    K Number: K160740 · Decision May 6, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    23
    Review Days
    50

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    Basic Information

    Device Name
    Medline ReNewal Reprocessed ENDOPATH XCEL Trocar with OPTIVIEW Technology
    K Number
    K160740
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Surgical Instrument Service and Savings, Inc.
    Date Received
    March 17, 2016
    Decision Date
    May 6, 2016
    Product Code
    NLM
    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
    NLM Laparoscope, General & Plastic Surgery, Reprocessed

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