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

    Anovo Surgical System (6Ne)

    K Number: K250591 · Decision Jun 6, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    7
    Applicant Total
    8
    Review Days
    99

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    Basic Information

    Device Name
    Anovo Surgical System (6Ne)
    K Number
    K250591
    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
    February 27, 2025
    Decision Date
    June 6, 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

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

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    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
    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