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

    Reprocessed Endoscopic Trocars and Sleeves

    K Number: K201511 · Decision Jul 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    17
    Registration Numbers
    17
    Same Product Code
    22
    Applicant Total
    32
    Review Days
    56

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    Basic Information

    Device Name
    Reprocessed Endoscopic Trocars and Sleeves
    K Number
    K201511
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stryker Sustainability Solutions
    Date Received
    June 5, 2020
    Decision Date
    July 31, 2020
    Product Code
    NLM
    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
    NLM Laparoscope, General & Plastic Surgery, Reprocessed

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