BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode

    K Number: K243182 · Decision Feb 3, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    126

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    Basic Information

    Device Name
    Anovo Instrument ARM Curved Scissors; Anovo Instrument ARM Hook Electrode
    K Number
    K243182
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4961
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Momentis Surgical , Ltd.
    Date Received
    September 30, 2024
    Decision Date
    February 3, 2025
    Product Code
    QNM
    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
    QNM Mountable Electromechanical Surgical System For Transluminal Approaches

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QNM), ordered by most recent decision date.

    Anovo Surgical System (Model 6Ne); Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

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    FDA Class 2 ·General, Plastic Surgery

    Anovo Surgical System (6Ne)

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    FDA Class 2 ·General, Plastic Surgery

    Anovo Instrument ARM Curved Scissors ; Anovo Instrument ARM Hook Electrode

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    FDA Class 2 ·General, Plastic Surgery

    Anovo Surgical System (Model 6Ne)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Anovo Surgical System (model 6N)

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    FDA Class 2 ·General, Plastic Surgery

    Anovo Pedestal

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Momentis Surgical , Ltd.

    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
    K242157 Anovo Surgical System (Model 6Ne)
    K241907 Anovo Surgical System (model 6N)
    K232146 Anovo Pedestal
    DEN190022 Hominis Surgical System