BEUDAMED
    Product Code: SCV FDA class 2 21 CFR 878.4964

    Modular Electromechanical Surgical System

    General, Plastic Surgery

    A modular electromechanical surgical system is a software-controlled electromechanical platform featuring multiple individual, fully positionable patient/device interfaces that enable a qualified surgeon to perform minimally invasive surgical procedures with flexible configuration. It is classified as FDA Class II (510(k) required) under regulation 878.4964 in the General and Plastic Surgery specialty, with product code SCV. The device is not an implant and does not support life-sustaining functions.

    View on FDA
    510(k)s
    3
    FEI Numbers
    15
    Registration Numbers
    15
    Unique Applicants
    2
    Years Active
    1

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    Basic Information

    Product Code
    SCV
    Device Class
    FDA class 2
    Regulation Number
    878.4964
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A modular electromechanical surgical system is a software-controlled electromechanical system with a plurality of individual, fully positionable patient/device interfaces which allows a qualified user to perform surgical techniques during minimally invasive surgical procedures.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 3 510(k) clearances via K numbers.

    K Number Device Name
    K252111 Versius Surgical System (Versius Plus)
    K250725 Hugo™ RAS System
    DEN230078 Versius Surgical System

    FEI Numbers

    This FDA classification entry is associated with 15 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 15 registration numbers. Click on an entry to view related FDA registrations.