# fda_de_novo (us_fda)

FDA De Novo clearance for CMR Surgical Versius (Oct 2024). Versius Plus 510(k) also filed.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_de_novo
- Status: cleared
- Filing date: 2024-10-01
- Decision date: 2024-10-01
- Verification posture: verified

## Applicant

- [CMR Surgical](/companies/cmr-surgical.md)

## Covered models (1)

- [Versius](/models/cmr-versius.md)

## Sources (1)

- [https://www.cmrsurgical.com/](https://www.cmrsurgical.com/)

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