{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-26-108792","form_type":"8-K","ticker":"SSII","cik":"0001676163","company_name":"SS Innovations International, Inc.","filed_at":"2026-10-13T13:26:00+00:00","discovered_at":"2026-10-13T13:27:00.258707+00:00","generated_at":"2026-10-13T13:27:04.535386+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"SS Innovations submits FDA response on SSi Mantra 510(k); decision expected Q1 2027","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-26-108792","json":"https://secwatch.observer/filing/0001213900-26-108792.json","markdown":"https://secwatch.observer/filing/0001213900-26-108792.md","text":"https://secwatch.observer/filing/0001213900-26-108792.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1676163/000121390026108792/0001213900-26-108792-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1676163/000121390026108792/ea0308357-8k_ssinnova.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-13T13:27:04.535386+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}