_Incident · Regulatory action_

# Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures

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

- **Occurred:** 2026-01-26
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Intuitive Surgical](/companies/intuitive-surgical.md) (id: `e5127536-0ff2-4f0e-8488-64994cb2ffc7`)

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.

## Sources (1)

1. 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.

### Who was involved in Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures?

The incident is recorded as involving Intuitive Surgical on the DEPLOY registry. No specific robot model is linked to this incident in the registry.

### 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.


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