SS Innovations submits FDA response with final data from expanded SSi Mantra clinical, human factors study
SSII•SS Innovations submitted an FDA response on Oct. 5, 2026, with final data from expanded clinical and human-factors validation and a bridging study completed in Colombia in August. FDA review of the response and the 510(k) is expected to conclude in the first quarter of 2027.
1. FDA submission
SS Innovations submitted its response to an FDA request tied to the SSi Mantra 510(k) filing on Oct. 5, 2026. The response included final data from an expanded human clinical and human-factors validation study and a bridging study completed in Colombia in August 2026.
2. Review timeline
The studies were intended to support the system’s safety and feasibility case for an initial U.S. indication in gallbladder removal. FDA review of the response and 510(k) is expected to conclude in the first quarter of 2027.
