Maestro System (REF100) is an AI-enabled medical device from Moon Surgical that the U.S. FDA cleared through 510(k) K242323 on March 14, 2025. Its lead review panel is General and Plastic Surgery and its primary product code is QZB (Software Controlled Endoscope And Instrument Holder).
See also all FDA AI clearances in 2025.
Key facts
| Submission number | K242323 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Moon Surgical |
| Lead review panel | General and Plastic Surgery |
| Primary product code | QZB — Software Controlled Endoscope And Instrument Holder |
| Applicant (openFDA) | Moon Surgical |
| Applicant location | Paris, FR |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.1500 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Maestro System (REF100) went through this pathway (K242323).
openFDA lists it as a Class 2 device under 21 CFR 876.1500. Class II devices are moderate risk and are subject to general and special controls.
Product code QZB covers 2 devices on the FDA AI list. By decision date, this device is #1 of 2 under that code. Moon Surgical has 2 AI-enabled devices on the list, and the General and Plastic Surgery panel accounts for 9 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.