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

    Versius Surgical System

    K Number: DEN230078 · Decision Oct 11, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    325

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    Basic Information

    Device Name
    Versius Surgical System
    K Number
    DEN230078
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    878.4964
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Cmr Surgical Limited
    Date Received
    November 21, 2023
    Decision Date
    October 11, 2024
    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

    Similar 510(k) Clearances

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    Other Clearances by Cmr Surgical Limited

    K Number Device Name
    K252111 Versius Surgical System (Versius Plus)