Maestro System (REF100) is an AI-enabled medical device from Moon Surgical, listed by FDA (510(k), K250984) with a decision date of 2025-06-27. Review panel: Gastroenterology-Urology.
| FDA submission number | K250984 |
|---|---|
| Pathway | 510(k) |
| Company | Moon Surgical |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2025-06-27 |
| Decision | Substantially Equivalent |
| Product code | QZB |
| Classification | Software Controlled Endoscope And Instrument Holder |
| Device class | 2 |
| Regulation number | 876.1500 |
| Review time (calendar days) | 88 |
| Applicant country | FR |
Official FDA database record · FDA AI-enabled device list
All Gastroenterology-Urology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.