---
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"
generated_at: "2026-10-13T13:27:04.535386+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# SS Innovations submits FDA response on SSi Mantra 510(k); decision expected Q1 2027

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-26-108792
- JSON: https://secwatch.observer/filing/0001213900-26-108792.json
- Plain text: https://secwatch.observer/filing/0001213900-26-108792.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.