Restore Robotics Secures FDA 510(k) Clearance for Remanufacturing Da Vinci Xi 8mm Monopolar Curved Scissors

Restore Robotics is pleased to announce it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for remanufacturing Da Vinci Xi Monopolar Scissors as of March 11, 2025 through its subsidiary Iconocare Health. With this milestone, Restore Robotics is offering hospitals and surgery centers a cost-effective and sustainable alternative to purchasing instruments from the original manufacturer.

Through its marketing and distribution partnership with Encore Medical Device Repair (Encore), Restore Robotics can efficiently deliver remanufactured instruments to hospitals and surgical centers across the U.S., expanding access to affordable, high-quality surgical tools.

"Restore Robotics is deeply committed to helping hospitals reduce the cost of using a surgical robot", says Restore Robotics CEO Clif Parker. "Our recent clearance is a break-through for robotic instrument re-use as the instrument cleared for remanufacturing is the most used robotic instrument in US hospitals."

Participating in the Restore Robotics and Encore remanufacturing program, hospitals can save a significant amount per year, freeing up budget resources for other critical needs.

"Encore was founded on the idea of instrument stewardship – we need to treat instruments as assets to keep costs down and protect the environment", says Encore President and COO Tom Milano. "Restore Robotics and Encore's collaboration on robotic instrumentation is a great win for resource stewardship."