secwatch.observer — SEC 8-K summary
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Issuer:     SS Innovations International, Inc. (SSII)
CIK:        0001676163
Form:       8-K
Filed at:   2026-10-13T13:26:00+00:00
Accession:  0001213900-26-108792
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

SS Innovations submits FDA response on SSi Mantra 510(k); decision expected Q1 2027
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- SSi submitted its response to the FDA's request for additional information (AINN) on October 5, 2026, regarding the 510(k) for its SSi Mantra surgical robotic system.
- Response includes final data from an expanded human clinical and human factors validation study plus a bridging study completed in August 2026 at Hospital Internacional de Colombia in Bucaramanga.
- SSi expects the FDA to complete review of the AINN response and the 510(k) in Q1 2027; the submission covers the initial indication of cholecystectomy (gallbladder removal).
- The company engaged Daniel & Daniel Consulting, LLC to assist with the AINN response, the validation study, the bridging study and the 510(k).
- CEO Sudhir Srivastava said the response brings SSi closer to U.S. market entry; the SSi Mantra has been clinically validated in India across more than 190 surgical procedure types.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1676163/000121390026108792/0001213900-26-108792-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1676163/000121390026108792/ea0308357-8k_ssinnova.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-108792

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