SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.

The CDRH is responsible for regulating firms who manufacture, repackage, relabel, or import medical devices sold in the United States. In addition, CDRH regulates medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment.

SS Innovations Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava, commented, “The filing of our pre-submission application with the CDRH is a pivotal step for SS Innovations, and provides an opportunity for us to gather feedback in an interactive meeting with the FDA prior to our planned 510(k) premarket submission for the SSi Mantra™ Surgical Robotic System. We are very pleased to have obtained regulatory approval for the SSi Mantra™ in India and Guatemala, and we are working towards obtaining approvals in the United States and Europe.”

The SSi Mantra™ Surgical Robotic System is the first surgical system to be made in India, and one of the only systems in the world to be distinctly cost-effective with broad-spectrum surgical applications, including cardiac surgery.