Regulatory filing

fda_510k (us_fda)

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

fda 510k · cleared · decided 2026-04-01

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Key facts

Jurisdiction: us_fda
Filing type: fda 510k
Status: cleared
Decision date: 2026-04-01

Covered models (1)

Maestro

Sources (1)

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

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Identity

ff749cec-2389-4c54-b88c-323ac3c67bf4