Restore Robotics Secures New FDA Clearances to Expand Remanufactured da Vinci Surgical Instruments Portfolio

01 April 2026 | News

Latest 510(k) approvals strengthen Restore Robotics’ leadership in sustainable robotic surgery, delivering cost savings and expanded access for hospitals nationwide.
Image Courtesy: Public Domain

Image Courtesy: Public Domain

Restore Robotics 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

"Expanding the number of remanufactured robotic instruments available to hospitals is a natural progression in advancing responsible healthcare," said Tom Milano, President and COO of Encore. "This continued collaboration represents a significant opportunity to improve both cost efficiency and environmental stewardship in surgical care."

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