# fda_510k (us_fda)

SS Innovations submitted 510(k) premarket notification to FDA on December 5, 2025 for SSi Mantra surgical robotic system. Changed course from De Novo to 510(k) pathway. Expects clearance in Q4.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: pending
- Decision date: 2025-12-05

## Covered models (1)

- [SSi Mantra](/models/ssi-mantra.md)

## Sources (1)

- [https://www.medtechdive.com/news/SS-Innovations-surgical-robot-FDA-submission/801859/](https://www.medtechdive.com/news/SS-Innovations-surgical-robot-FDA-submission/801859/)

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