regulatory
confidence high
sentiment positive
materiality 0.65
SS Innovations submits 510(k) to FDA for SSi Mantra surgical robot; installed base reaches 138 systems
SS Innovations International, Inc.
- Submitted 510(k) premarket notification to FDA on Dec 5, 2025 for SSi Mantra system covering general, urological, colorectal, gynecological, and cardiac surgeries.
- EU CE marking certification expected in first half of 2026.
- Cumulative installed base of 138 systems across 8 countries; 7,300+ procedures performed including 88 telesurgeries and 390 cardiac.
- FDA targets 90-day review cycle for 510(k) submissions; actual approval timing may vary.