BEUDAMED
    Product Code: QNM FDA class 2 21 CFR 878.4961

    Mountable Electromechanical Surgical System For Transluminal Approaches

    General, Plastic Surgery

    The Mountable Electromechanical Surgical System for Transluminal Approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical system with human/device interfaces that enables a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4961 in the General and Plastic Surgery specialty. It carries product code QNM and is not an implant and not life-sustaining.

    View on FDA
    510(k)s
    8
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    1
    Years Active
    4

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    Basic Information

    Product Code
    QNM
    Device Class
    FDA class 2
    Regulation Number
    878.4961
    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 mountable electromechanical surgical system for transluminal approaches is a software-controlled, patient bed- and/or operating table-mounted electromechanical surgical system with human/device interfaces that allows a qualified user to perform transluminal endoscopic or laparoscopic surgical procedures using surgical instruments attached to an electromechanical arm.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 8 510(k) clearances via K numbers.

    K Number Device Name
    K251761 Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
    K250591 Anovo Surgical System (6Ne)
    K251056 Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode
    K243182 Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
    K242157 Anovo Surgical System (Model 6Ne)
    K241907 Anovo Surgical System (model 6N)
    K232146 Anovo Pedestal
    DEN190022 Hominis Surgical System

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.