# SS Innovations Files Final FDA Response for SSi Mantra Surgical System

- URL: https://stocks.freetheai.org/news/ss-innovations-files-final-fda-response-for-ssi-mantra-surgical-system-5abc2e
- Published: 2026-10-14T14:52:05Z
- Category: regulation; sentiment: neutral; impact: medium
- Symbols: [NASDAQ:SSII](https://stocks.freetheai.org/symbols/NASDAQ-SSII)
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SS Innovations International, Inc. (SSII) submitted its response to an FDA additional information request on October 5, 2026, advancing the clearance process for its SSi Mantra surgical system. The filing contains final clinical and human factors data, alongside findings from a bridging study finished in August 2026.

The submission focuses on an initial indication for cholecystectomy, or gallbladder removal. Securing regulatory clearance is a crucial step for the company, as it is required before commercial sales can begin in the United States.

SS Innovations expects the FDA to finish its review during the first quarter of 2027. Clearance would allow the company to launch U.S. commercial operations and begin generating revenue from the platform. Shares of the company last traded down 1.96% at $2.50.

## Key points

- SS Innovations International, Inc. submitted its FDA response for the SSi Mantra on October 5, 2026.
- The submission includes final clinical and human factors data plus bridging study results from August 2026.
- The initial regulatory application covers cholecystectomy, commonly known as gallbladder removal.
- The company expects the FDA to complete its 510(k) review in the first quarter of 2027.
- FDA clearance is required before commercial distribution can start in the United States market.

## Questions and answers

### When does SS Innovations expect FDA review completion for the SSi Mantra?

SS Innovations expects the FDA to complete its 510(k) review in the first quarter of 2027.

### What procedure is targeted in the initial SSi Mantra FDA filing?

The initial submission targets cholecystectomy, which is gallbladder removal.

### What data did SS Innovations include in its FDA submission?

The response included final clinical and human factors data, along with a bridging study completed in August 2026.