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510(k) Data Aggregation
K Number
K250984Device Name
Maestro System (REF100)
Manufacturer
Moon Surgical
Date Cleared
2025-06-27
(88 days)
Product Code
QZB
Regulation Number
876.1500Why 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
K242323Device Name
Maestro System (REF100)
Manufacturer
Moon Surgical
Date Cleared
2025-03-14
(220 days)
Product Code
QZB
Regulation Number
876.1500Why 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
K240598Device Name
Maestro System (REF100)
Manufacturer
Moon Surgical
Date Cleared
2024-06-03
(91 days)
Product Code
FQO, QZB
Regulation Number
878.4960Why 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
K221410Device Name
Maestro Platform
Manufacturer
Moon Surgical
Date Cleared
2022-12-02
(200 days)
Product Code
FQO
Regulation Number
878.4960Why 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.
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