Regulatory filing

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.

fda 510k · pending

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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

Covered models (1)

SSi Mantra

Sources (1)

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

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Identity

3f698db3-9791-423e-a474-6172bf458028