SS Innovations Submits Response to FDA Request for Additional Information Regarding the Company’s 510(k) Submission for the SSi Mantra
SS Innovations submitted its response on October 5, 2026 to an FDA additional-information request regarding its 510(k) submission 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 at Hospital Internacional de Colombia, a Mayo Clinic Care Network member in Bucaramanga. The FDA is expected to complete its review in the first quarter of 2027, with the initial indication being cholecystectomy (gallbladder removal). CEO Dr.
Key figures
- Drug Name
- SSi Mantra surgical robotic system
- Phase Of Trial
- 510(k) premarket notification review
- Fda Decision Window
- Q1 2027
- Initial Indication
- cholecystectomy
- Clinical Procedures Validated
- more than 190
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