SS Innovations files FDA 510(k) for the SSi Mantra surgical robot

SS Innovations International/SSi Mantra

SS Innovations asked the FDA to clear SSi Mantra for general, urological, colorectal, gynaecological and cardiac surgery. It chose the faster 510(k) route, which compares a device with ones already on the market, over a De Novo request.

• Submitted on December 5, 2025, after a pre-submission meeting with the FDA.
• FDA aims to review 510(k)s in 90 days, but total time often runs longer.
• The company then expected a CE mark in the first half of 2026.