BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇧 United Kingdom

    Versius Surgical System (Versius Plus)

    K Number: K252111 · Decision Dec 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    162

    Basic Information

    Device Name
    Versius Surgical System (Versius Plus)
    K Number
    K252111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4964
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cmr Surgical Limited
    Date Received
    July 7, 2025
    Decision Date
    December 16, 2025
    Product Code
    SCV
    Advisory Committee
    General, Plastic Surgery
    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
    SCV Modular Electromechanical Surgical System

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    K Number Device Name
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