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Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments

[REGULATORY ACTION]

Mar 31, 2026 · Restore Robotics · Remanufactured da Vinci Xi EndoWrist Instruments · Germany, Europe

All Incidents

Failure Mode

REGULATORY ACTION

Event Date

Mar 31, 2026

Primary Entity

Restore Robotics

Robotic Platform

Remanufactured da Vinci Xi EndoWrist Instruments

Jurisdiction / Location

Germany, Europe

Audit Standard

Physical State Verified

Incident Abstract & Audit Findings

Restore Robotics announced FDA 510(k) clearances (K252926) for remanufacturing two additional da Vinci Xi robotic surgical instruments: the Permanent Cautery Hook and Permanent Cautery Spatula. The company now holds four FDA clearances for Intuitive Surgical da Vinci instruments. Intuitive Surgical has granted contractual approval for Restore Robotics to remanufacture any EndoWrist instrument covered by FDA 510(k) clearance.

System & Fleet Architecture

Operating Manufacturer

Restore RoboticsView Manufacturer

Hardware Platform

Remanufactured da Vinci Xi EndoWrist Instruments

Operational Sectors

Physical AI / Robotics

Primary Sources & Evidentiary Filings

  • https://www.medtechdive.com/news/restore-robotics-fda-510k-clearance-remanufacture-intuitive-surgical-da-vinci-instruments/816611/

    https://www.medtechdive.com/news/restore-robotics-fda-510k-clearance-remanufacture-intuitive-surgical-da-vinci-instruments/816611/

  • https://www.prnewswire.com/news-releases/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments-302729165.html

    https://www.prnewswire.com/news-releases/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments-302729165.html

Related Incidents & Failure Precedents

6 records on file

Incident Context & FAQ

What happened in Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments?

Restore Robotics announced FDA 510(k) clearances (K252926) for remanufacturing two additional da Vinci Xi robotic surgical instruments: the Permanent Cautery Hook and Permanent Cautery Spatula. The company now holds four FDA clearances for Intuitive Surgical da Vinci instruments. Intuitive Surgical has granted contractual approval for Restore Robotics to remanufacture any EndoWrist instrument covered by FDA 510(k) clearance.

When did this incident occur?

The incident is recorded as occurring on March 31, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

What robot was involved in Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments?

Remanufactured da Vinci Xi EndoWrist Instruments by Restore Robotics is the recorded robot involved in this incident at Germany, Europe.

Has anyone responded to Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments?

No responses to this incident are recorded on the DEPLOY registry. Operators, manufacturers, or affected parties can submit responses to the editorial team; absence is not a guarantee no response was issued.

What is the current status of Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.