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Incident · Regulatory action

Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures

Intuitive Surgical received FDA 510(k) clearance for da Vinci 5 robotic surgical system for cardiac procedures. Limited US sites to begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.

Occurred 2026-01-26 · da Vinci (and Ion) at South Korea · Intuitive Surgical · South Korea · Surgical robots · 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 (3)

  1. https://isrg.intuitive.com/news-releases/news-release-details/da-vinci-5-cleared-cardiac-procedures · 2026-01-26
  2. https://isrg.intuitive.com/node/22631/pdf · 2026-01-26
  3. https://www.massdevice.com/intuitive-fda-510k-clearances-cardiac-procedures-da-vinci-5/

Status history

  • Active · 2026-07-03 · agent:depth

Common questions

What happened in Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures?
Intuitive Surgical received FDA 510(k) clearance for da Vinci 5 robotic surgical system for cardiac procedures. Limited US sites to begin working with Intuitive through 2026 to establish da Vinci 5 cardiac programs.
When did this incident occur?
The incident is recorded as occurring on January 26, 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 Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures?
da Vinci (and Ion) by Intuitive Surgical is the recorded robot involved in this incident at South Korea.
Has anyone responded to Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures?
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 Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.
Methodology: Verified · 3 sources (no primary) · last reviewed 2026-07-14

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

3
unclassified
Unclassified source

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

Methodology surface for Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures.

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Canonical ID d4df3a39-ec40-4531-9327-935a84887890