FOR IMMEDIATE RELEASE
Restore Robotics Receives FDA 510(k) Clearance for Two Additional da Vinci Xi® Robotic Instruments
HENDERSON, NV – March 31, 2026
Restore Robotics today announced it has received additional 510(k) clearances from the U.S. Food and Drug Administration (FDA) for the remanufacturing of two more da Vinci Xi® robotic surgical instruments. This milestone expands Restore Robotics’ growing portfolio of cleared instruments and further strengthens its position as a leader in robotic instrument remanufacturing.
With these latest clearances, Restore Robotics continues to deliver on its mission to provide hospitals and surgery centers with cost-effective, high-quality, and sustainable alternatives to purchasing new robotic instruments from original equipment manufacturers.
“These additional FDA clearances mark another major step forward in our effort to transform the economics of robotic surgery,” said Clif Parker, CEO of Restore Robotics. “By expanding our remanufacturing capabilities across more high-utilization instruments, we are enabling healthcare providers to significantly reduce costs while maintaining the performance and reliability surgeons expect.”
Through its established partnership with Encore Medical Device Repair, Restore Robotics will continue to scale distribution of its remanufactured instruments nationwide. The expanded product offering allows hospitals to capture greater savings across a broader portion of their robotic instrument spend.
Hospitals participating in the Restore Robotics remanufacturing program benefit from:
· Meaningful cost reductions versus OEM instruments
· Increased sustainability through instrument reuse
· Seamless integration into existing robotic surgery workflows
“Bringing additional robotic instruments through the FDA clearance process is a monumental task, and this milestone is a direct result of the dedication and expertise of our engineering and regulatory teams,” said Kevin May, COO of Restore Robotics. “Their work is forging the way for hospitals to access more sustainable robotic instrument solutions while realizing significant cost savings across their robotic surgery systems.”
About Restore Robotics
Based in Panama City Beach, Florida, with a state-of-the-art remanufacturing facility in Henderson, Nevada, Restore Robotics is a pioneer in surgical robotics remanufacturing. The company offers innovative solutions that enhance the performance, sustainability, and affordability of surgical systems worldwide.
www.restorerobotics.com | info@restorerobotics.net | 678-619-0011
About Encore Medical Device Repair
As a complement to its instrument repair services, Encore Medical Device Repair collects and distributes remanufactured medical instruments with a focus on quality and sustainability. Encore, through Restore Robotics, enables hospitals to reduce costs while maintaining the highest safety and performance standards.
www.encoremdr.com |
info@encoremdr.com | 480.687.0271
Intuitive Surgical, Inc. has granted approval under its contracts for Restore Robotics to remanufacture any EndoWrist that falls under the scope of any 510(k) clearance from the FDA. Disclaimer: da Vinci®, da Vinci Xi® are registered trademarks of Intuitive Surgical, Inc. 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.
Media Contact:
Restore Robotics
Clif Parker, CEO
info@restorerobotics.net
678-619-0011