Restore Robotics Expands FDA-Cleared Portfolio for da Vinci Instruments

Restore Robotics has received additional 510(k) clearance from the Food and Drug Administration for two remanufactured instruments used with da Vinci Xi by Intuitive Surgical.

The newly cleared devices include the permanent cautery hook and cautery spatula, bringing Restore’s total FDA-cleared da Vinci instruments to four. Previous approvals covered monopolar curved scissors for both da Vinci Xi and Si systems.

The da Vinci Xi remains one of the most widely used robotic surgery platforms globally, with newer models like the da Vinci 5 driving continued growth.

Restore aims to offer hospitals cost-effective and sustainable alternatives by remanufacturing high-use surgical tools. The latest approvals strengthen efforts to reduce surgical costs without compromising performance.

The company plans to expand nationwide distribution through its partnership with Encore Medical Device Repair.

03-04-2026