Intuitive Surgical da Vinci 5 receives FDA clearance for cardiac procedures
[REGULATORY ACTION]Jan 26, 2026 · Intuitive Surgical · da Vinci (and Ion) · South Korea
Failure Mode
REGULATORY ACTION
Event Date
Jan 26, 2026
Primary Entity
Intuitive Surgical
Robotic Platform
da Vinci (and Ion)
Jurisdiction / Location
South Korea
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.massdevice.com/intuitive-fda-510k-clearances-cardiac-procedures-da-vinci-5/
https://www.massdevice.com/intuitive-fda-510k-clearances-cardiac-procedures-da-vinci-5/
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Details
Incident Context & FAQ
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.