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

    Reprocessed Covidien Trocar

    K Number: K172093 · Decision Oct 5, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    86

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    Basic Information

    Device Name
    Reprocessed Covidien Trocar
    K Number
    K172093
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Renovo, Inc.
    Date Received
    July 11, 2017
    Decision Date
    October 5, 2017
    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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