SS Innovations submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system for multiple specialty procedure types.
The submission covers indications including general, urological, colorectal, gynecological, and cardiac surgeries.
The Company aims to introduce its cost-efficient SSi Mantra surgical robotic system to the U.S. market.
FDA Submission
Submitted a 510(k) premarket notification to the FDA for the SSi Mantra surgical robotic system.
Specialties Covered
Indications include general, urological, colorectal, gynecological, and cardiac surgeries.
Market Strategy
Focused on affordability, differentiated technology, and performance for hospitals and surgeons in the U.S.
Regulatory Progress
Pursuing CE marking certification in the European Union in the first half of 2026.
- The 510(k) submission to the FDA marks a significant milestone in the Company's strategic plan for market entry.
- FDA reviews for 510(k) submissions aim to be completed within 90 days, but approval time may vary due to certain factors.
SS Innovations is strategically positioning the SSi Mantra robotic system for global expansion and regulatory approvals.