# fda_510k (us_fda)

Moon Surgical received FDA 510(k) clearance. AI/ML medical device with 2 clearances in 2025 review.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: cleared
- Decision date: 2026-04-01

## Covered models (1)

- [Maestro](/models/moon-maestro.md)

## Sources (1)

- [https://innolitics.com/articles/year-in-review-ai-ml-medical-device-k-clearances/](https://innolitics.com/articles/year-in-review-ai-ml-medical-device-k-clearances/)

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