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Incident · Regulatory action

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.

Occurred 2026-03-31 · Restore Robotics · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
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Sources (2)

  1. MedTech Dive · https://www.medtechdive.com/news/restore-robotics-fda-510k-clearance-remanufacture-intuitive-surgical-da-vinci-instruments/816611/
  2. PR Newswire · https://www.prnewswire.com/news-releases/restore-robotics-receives-fda-510k-clearance-for-two-additional-da-vinci-xi-robotic-instruments-302729165.html

Status history

  • Active · 2026-08-18 · agent:recon

Common questions

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.
Who was involved in Restore Robotics receives FDA 510(k) clearance for two additional da Vinci Xi robotic surgical instruments?
The incident is recorded as involving Restore Robotics on the DEPLOY registry. No specific robot model is linked to this incident in the registry.
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.
Methodology: Verified · 2 sources (no primary) · last reviewed 2026-08-18

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-08-18

Sources by quality tier

1
secondary-trade-publication
Trade publication
1
unclassified
Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

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

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Canonical ID 54c690eb-ae93-484b-872f-88de21a13fcd