Monitor for FDA 510(k) clearance decision expected in Q1 2027 — clearance would open the U.S. market for the SSi Mantra, a binary catalyst for this pre-revenue medtech. Watch for any additional FDA information requests or clinical data disclosures before that date.
Price Chart
Executive Summary
SS Innovations submitted its response to an FDA request for additional information (AINN) regarding its 510(k) application for the SSi Mantra surgical robotic system. The response includes final data from an expanded human clinical and human factors validation study and a bridging study completed in August 2026. The company expects FDA review completion in Q1 2027, marking a procedural step forward but with no guarantee of approval.
Key Facts
- Response to FDA AINN submitted on October 5, 2026
- Includes final data from expanded human clinical and human factors validation study
- Includes final data from bridging study completed August 2026 at Hospital Internacional de Colombia
- FDA review of AINN response and 510(k) submission anticipated in Q1 2027
- Initial indication is cholecystectomy (gallbladder removal)
- Company engaged Daniel & Daniel Consulting, LLC for assistance
Financial Impact
No financial figures provided in the filing; the event is a regulatory milestone with no disclosed revenue, costs, or deal values.
Risk Factors
- FDA may request further information or deny the 510(k) clearance, delaying or preventing U.S. market entry
- No current U.S. revenue stream — the company remains pre-revenue in its target market
- Competitive landscape includes established robotic surgery systems (e.g., da Vinci by Intuitive Surgical)
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001213900-26-108792 |
| Document: ea030835701ex99-1.htm | 0001213900-26-108792 |
| Document: 0001213900-26-108792-index-headers.html | 0001213900-26-108792 |
| Document: 0001213900-26-108792-index.html | 0001213900-26-108792 |
| Document: 0001213900-26-108792.txt | 0001213900-26-108792 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 26, 2026 today | 8-K | — | awaiting T+5 | — | — |
Oct 26, 2026 today | Press Release | — | awaiting T+5 | — | — |
Oct 13, 2026 13d ago | 8-K | $2.55 $2.54 | ▼ −0.39% | ▲ +0.76% | $2.37 (−7.06%) |
Oct 13, 2026 13d ago | 8-K | $2.55 $2.54 | ▲ +0.39% | ▼ −0.76% | $2.37 (+7.06%) |
Oct 9, 2026 16d ago | 424B5 | $2.55 $2.45 | ▲ +3.92% | ▲ +2.43% | $2.37 (+7.06%) |
Oct 5, 2026 21d ago | 8-K | $2.77 $2.55 | ▼ −7.94% | ▼ −8.36% | $2.37 (−14.44%) |
Sep 10, 2026 6w ago | 8-K | $3.30 $3.26 | ▼ −1.21% | ▼ −0.71% | $2.37 (−28.18%) |
Aug 13, 2026 10w ago | 8-K | $3.83 $3.61 | ▼ −5.74% | ▼ −3.78% | $2.37 (−38.12%) |
Jul 17, 2026 14w ago | 8-K | $3.64 $3.57 | ▼ −1.92% | ▼ −1.24% | $2.37 (−34.89%) |
Jul 14, 2026 14w ago | 8-K | $3.67 $3.75 | ▲ +2.18% | ▲ +3.48% | $2.37 (−35.42%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers