# fda_510k (us_fda)

SS Innovations submitted 510(k) for SSi Mantra Surgical Robotic System to FDA Dec 8, 2025. Pivoted from De Novo to 510(k) pathway.

## Key facts

- Jurisdiction: us_fda
- Filing type: fda_510k
- Status: pending
- Filing date: 2025-12-08
- Verification posture: verified
- Cap-flag notes: Pending review. Pivoted from De Novo to 510(k).

## Applicant

- [SS Innovations International](/companies/ss-innovations.md)

## Covered models (1)

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

## Sources (1)

- [https://finance.yahoo.com/news/ss-innovations-submits-510-k-133000188.html](https://finance.yahoo.com/news/ss-innovations-submits-510-k-133000188.html)

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