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510(k) Data Aggregation

    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
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    Matched: '878.4960'

    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?
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    Matched: '878.4960'

    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?
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    Matched: '878.4960'

    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.
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    K Number
    K090136
    Device Name
    STERIS CMAX XLT SURGICAL TABLE
    Manufacturer
    STERIS Corporation
    Date Cleared
    2009-03-20

    (58 days)

    Product Code
    FQO, FOO
    Regulation Number
    878.4960
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    Matched: '878.4960'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The STERIS® 5085 SRT is a general surgical table with high patient weight capacity, extended width capability, and lower minimal table top elevation. The STERIS® 5085 SRT accommodates all general surgical procedures including but not limited to, cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmologic, orthopedics and other procedures requiring intraoperative fluoroscopic C-arm imaging and also supports laparoscopic surgical technique for the largest surgical patients. The STERIS® 5085 SRT enables patient transport on hard level surfaces within the surgical suite (from pre-operative areas to the operating room and again from the operating room to post operative recovery).
    Device Description
    The STERIS® 5085 SRT Surgical Table is a mobile, electro-hydraulically operated surgical table designed to support all general surgical procedures including cardiac and vascular, endoscopic, gynecology, urology, nephrectomy, neurology, ophthalmology and orthopedics with the addition of STERIS table accessories. The STERIS® 5085 SRT Surgical Table features powered lateral tilt, Trendelenburg / reverse Trendelenburg, Zip-Slide™ movable tabletop, and adjustable height functions. The STERIS® 5085 SRT has a patient transport feature that allows the user to transport patients to and from the surgical suite on hard level surfaces.
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    K Number
    K080506
    Device Name
    MARTIN CHAIR, MODEL C4S1
    Manufacturer
    MARTIN MANUFACTURING CO., LLC
    Date Cleared
    2008-06-09

    (105 days)

    Product Code
    IOR, LGX
    Regulation Number
    890.3850
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    Matched: '878.4960'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Martin Chair Model C4S1 is indicated for providing mobility to persons limited to a sitting position. It is also specifically indicated to transfer a patient to and from the Martin Examination Table. The Martin Examination Table is indicated for use during diagnostic examinations or surgical procedures to support and position a patient.
    Device Description
    The Martin Chair Model C4S1 mechanical wheelchair is an indoor/outdoor wheelchair that has a base with two larger rear wheels and two smaller front wheels and a seat. The wheelchair is intended to be manually propelled by a person seated in the wheelchair or by an attendant or clinician. The device is made from composites of steel, plastics and fabrics. The wheelchair is for use by adult persons. The wheelchair can be secured to a compatible, electrically elevated examination table which allows for the seat of the wheelchair to become part of the examination table. This removes the need for the patient to be lifted during transfer from the wheelchair to the examination table. The wheelchair is latched to the examination table and the side frame and wheels are removed for the examination. The sides and wheels are replaced prior to lowering the examination table allowing the wheelchair to be used according to its intended use. The Martin Examination Table is a 510(k) exempt device, 21 CFR 878.4960, product code LGX. It is an accessory to the Martin Chair. It is a device intended as a powered examination table to provide positioning and support to patients during general examinations and procedures. It is intended for medical purposes as an electrically operated table with movable components that can be adjusted to various positions, the same intended use as other currently marketed powered tables. The Martin Examination Table is a standard powered examination table that includes standard components and features of other currently marketed powered examination tables including side rails for additional safety. The Martin Examination Table includes latches under the seat cushion that are compatible with the fixed metal receivers of the Martin Chair Model C4S1,
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    K Number
    K965001
    Device Name
    INTUITIVE SURGICAL MONARCH LAPAROSCOPIC MANIPULATOR
    Manufacturer
    INTUITIVE SURGICAL, INC.
    Date Cleared
    1997-07-31

    (227 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
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    Matched: '878.4960'

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
    Device Description
    The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.
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