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

HENDERSON, Nev., March 25, 2025 /PRNewswire/ — 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.”

About Restore Robotics
Based in Panama City Beach, Florida, with a state-of-the-art remanufacturing facility in Henderson, NV, Restore Robotics is a pioneer in the surgical robotics field, offering innovative solutions that enhance the performance and sustainability of surgical systems.

About Encore Medical Device Repair
Encore Medical Device Repair was founded in 2022 on the vision that device and instrument reuse should play a key role in responsible healthcare. To achieve this, the founders knew they had to raise the level of quality, sophistication, transparency, and service in the industry. A focus on the highest-price, highest-utilization instrument categories allows Encore to employ the most qualified technicians and deliver unparalleled service while containing costs.

For more information about Restore, please visit www.restorerobotics.com or contact:

Clif Parker
CEO, Restore Robotics
info@restorerobotics.net
678-619-0011

Disclaimer: Da Vinci, Da Vinci Xi, and Da Vinci Si are registered trademarks of Intuitive Surgical. Restore Robotics is an independent entity and is not affiliated with Intuitive Surgical®, Inc. or its affiliates. All registered trademarks and product names mentioned herein are the property of their respective owners.

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SOURCE Restore Robotics