SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra
Key Highlights
- ➤SS Innovations submitted FDA response October 5 for SSi Mantra 510(k) review
- ➤Response includes final expanded human clinical and human factors validation data
- ➤Bridging Study completed August 2026 at Hospital Internacional de Colombia
- ➤FDA review of response and 510(k) submission anticipated in Q1 2027
- ➤510(k) submission covers initial cholecystectomy indication
Expert Statements
Sudhir Srivastava, Chairman of the Board and Chief Executive Officer of SS Innovations
“In response to the FDA’s request for additional information, we completed an expanded human clinical and human factors validation study for our SSi Mantra surgical robotic system. Our response to the FDA’s AINN brings us closer to our goal of introducing our advanced, cost-efficient SSi Mantra surgical robotic system to the U.S. market.”
FORT LAUDERDALE, Fla., Oct. 13, 2026 (GLOBE NEWSWIRE) -- via IBN -- SS Innovations International, Inc. (the “Company” or “SS Innovations”) (NASDAQ: SSII), a developer of innovative surgical robotic technologies dedicated to making robotic surgery affordable and accessible to a global population, today announced that, on October 5, 2026, the Company submitted its response to a request for additional information letter (the “AINN”) received from the United States Food and Drug Administration (the “FDA”) with regard to the Company’s 510(k) submission for its SSi Mantra surgical robotic system (the “SSi Mantra”).
The Company’s response to the AINN includes final data from an expanded human clinical and human factors validation study (the “Study”) for the SSi Mantra. The completion of the Study was designed to provide essential evidence that the SSi Mantra meets the FDA’s requirements for safety, efficacy and feasibility, and is an important part of the Company’s 510(k) premarket notification.
Get started
Create a free account to read the full story.