SS Innovations submits response to FDA information request on SSi Mantra 510(k) filing
Bitget2026/10/13 12:31- SS Innovations submitted its response to an FDA request for additional information on its 510(k) filing for the SSi Mantra.
- The package includes final data from expanded human clinical and human factors validation work, plus a bridging study completed in August 2026.
- FDA review of the response and the 510(k) is expected to conclude in Q1 2027 for an initial cholecystectomy indication.
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