Maestro System (REF100) is an AI-enabled medical device from Moon Surgical that the U.S. FDA cleared through 510(k) K250984 on June 27, 2025. Its lead review panel is Gastroenterology-Urology and its primary product code is QZB (Software Controlled Endoscope And Instrument Holder).
See also FDA-cleared AI gastroenterology-urology devices in 2025, all FDA AI clearances in 2025, top gastroenterology-urology AI devices.
Key facts
| Submission number | K250984 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Moon Surgical |
| Lead review panel | Gastroenterology-Urology |
| 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 (K250984).
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 #2 of 2 under that code. Moon Surgical has 2 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.