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510(k) Data Aggregation

    K Number
    K250984
    Device Name
    Maestro System (REF100)
    Manufacturer
    Moon Surgical
    Date Cleared
    2025-06-27

    (88 days)

    Product Code
    QZB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moon Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
    Device Description
    The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being is being submitted to implement 5G and WiFi capability to the previously cleared Maestro System (K242323). This modification is intended for data offload; only Telemetry and Event logs will be sent over 5G or WiFi. A PCCP is also implemented for the ScoPilot feature.
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    K Number
    K242323
    Device Name
    Maestro System (REF100)
    Manufacturer
    Moon Surgical
    Date Cleared
    2025-03-14

    (220 days)

    Product Code
    QZB
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moon Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
    Device Description
    The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement the ScoPilot feature. ScoPilot is an on-demand, optional, ease-of-use feature of the Maestro System, allowing the laparoscope which is attached to a Maestro Arm to seamlessly follow a desired instrument tip. The surgeon remains in control of laparoscope positioning, without having to disengage from the instrument in their hand, helping maintain surgical flow and focus.
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    K Number
    K240598
    Device Name
    Maestro System (REF100)
    Manufacturer
    Moon Surgical
    Date Cleared
    2024-06-03

    (91 days)

    Product Code
    FQO, QZB
    Regulation Number
    878.4960
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moon Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro System is intended to hold and position laparoscopes and laparoscopic instruments during laparoscopic surgical procedures.
    Device Description
    The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location. This 510(k) is being submitted to implement design changes to the previously cleared Maestro System. The following modifications have been implemented to the Maestro System: - · System Positioning Guidance - · System Hold Status Indication - Instrument Coupling - · System Setup - Bedside Setup Joint Control
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    K Number
    K221410
    Device Name
    Maestro Platform
    Manufacturer
    Moon Surgical
    Date Cleared
    2022-12-02

    (200 days)

    Product Code
    FQO
    Regulation Number
    878.4960
    Why did this record match?
    Applicant Name (Manufacturer) :

    Moon Surgical

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maestro System is intended to hold and position laparoscopic instruments during laparoscopic surgical procedures.
    Device Description
    The Moon Maestro System utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position. Motors compensate for gravitational force applied to laparoscopic instruments, while surgeon control is not affected. Conventional laparoscopic tools are exclusively controlled and maneuvered by the surgeon, who grasps the handle of the surgical laparoscopic instrument and moves it freely until the instrument is brought to the desired position. Once surgeon hand force is removed, the Maestro system reverts to maintenance of the specified tool position and instrument tip location.
    Ask a Question

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