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

    da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)

    K Number: K223080 · Decision Nov 22, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    98
    Registration Numbers
    98
    Same Product Code
    148
    Applicant Total
    9
    Review Days
    53

    Basic Information

    Device Name
    da Vinci X Surgical System (IS4200), da Vinci Xi Surgical System (IS4000)
    K Number
    K223080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.1500
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Intuitive Surgical, Inc
    Date Received
    September 30, 2022
    Decision Date
    November 22, 2022
    Product Code
    NAY
    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
    NAY System, Surgical, Computer Controlled Instrument

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