Maestro System (REF100)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Maestro System EUDAMED
- Model / Reference
- Maestro System EUDAMEDREF 101 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 37700258490656 EUDAMED
- Basic UDI-DI
- 3770025849101YD EUDAMED
- Direct Marketing DI
- 37700258490656 EUDAMED
- 510(k) Number
- K250984 FDA 510(k)
- FDA Product Code
- QZB FDA 510(k)
- EMDN Code
- Z12029099 VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI–INVASIVE SURGERY – OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Market of Registration
- France EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Maestro System (REF100) is a Software-Controlled Endoscope and Instrument Holder, classified as a Class II medical device. It integrates robotic arms to support and manipulate endoscopic instruments and scopes during minimally invasive procedures, enhancing precision and ergonomic control for surgeons in gastroenterology and urology.
This system is designed for use in operating rooms, providing adjustable, gravity-assisted arm configurations to hold instruments and endoscopes without manual clutching or foot pedals. Supplied as a reusable device, it requires proper sterilisation and maintenance per manufacturer guidelines. Authorised under FDA 510(k) clearance and MDR compliance, the Maestro System (REF100) operates within MRI-safe parameters for the specified configurations and is regulated under product code QZB.
Frequently asked questions
What types of surgical procedures is the Maestro System (REF100) designed to assist with, and how does it improve the surgeon’s experience?
The Maestro System (REF100) is specifically designed to support minimally invasive procedures in gastroenterology and urology, where precise instrument and endoscope control are critical. It uses robotic arms to hold tools and scopes, eliminating the need for manual clutching or foot pedals. This design enhances ergonomics by reducing surgeon fatigue and improves precision through adjustable, gravity-assisted arm configurations, allowing for smoother, more controlled movements during surgery.
Is the Maestro System (REF100) reusable, and what sterilization or maintenance steps are required?
Yes, the Maestro System (REF100) is a reusable device, meaning it must be properly sterilized and maintained according to the manufacturer’s guidelines to ensure safety and functionality. Since it is used in operating rooms, adherence to sterilization protocols is essential to prevent contamination between procedures.
Can the Maestro System (REF100) be used in an MRI environment, and if so, what limitations apply?
The Maestro System (REF100) is designed to operate within MRI-safe parameters for specified configurations, meaning it can be used in MRI-compatible settings under the conditions outlined by the manufacturer. However, exact limitations—such as arm positioning, weight restrictions, or compatibility with specific MRI machines—should be verified with Moon Surgical’s technical documentation to ensure safe use.
How is the Maestro System (REF100) regulated, and what does its classification as a Class II device mean for its use?
The Maestro System (REF100) is classified as a Class II medical device under FDA regulations and has received 510(k) clearance, meaning it has been determined to be substantially equivalent to a legally marketed device. This classification indicates that it undergoes stricter regulatory oversight than Class I devices but does not require the same rigorous pre-market approval process as Class III devices. Clinicians should ensure compliance with manufacturer guidelines and institutional protocols when integrating it into their workflow.
What are the key differences between the Maestro System (REF100) and traditional manual endoscope holders in terms of setup and flexibility?
Unlike traditional manual endoscope holders, which rely on the surgeon’s hands or foot pedals for control, the Maestro System (REF100) uses software-controlled robotic arms to hold instruments and scopes. This design provides adjustable, gravity-assisted arm configurations, reducing physical strain and allowing for more precise, ergonomic positioning. The system is also designed for operating room use, offering flexibility in procedure setups without requiring constant manual adjustments.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Maestro Platform | Moon Surgical, Keine Maestro-Funktion mehr für Girokarten - Verbraucherzentrale.de, Home | Moon Surgical, PDF Moon Surgical ℅ Michael Daniel Consultant Daniel & Daniel Consulting
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K250984 | Class II | Active |
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Manufacturer
- Manufacturer
- Moon Surgical, Inc.
- FDA Applicant
- Moon Surgical
Sources (2)
- FDA 510(k) K250984 24 fields · synced Sep 18, 2026
- EUDAMED 2327c238-93b9-4ab3-8697-07ce3ae2cf50 61 fields · synced Aug 3, 2026