FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures
[REGULATORY ACTION]Dec 3, 2025 · Medtronic · Hugo RAS · Dublin, Ireland
Failure Mode
REGULATORY ACTION
Event Date
Dec 3, 2025
Primary Entity
Medtronic
Robotic Platform
Hugo RAS
Jurisdiction / Location
Dublin, Ireland
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
On December 3, 2025, the FDA cleared Medtronic's Hugo robotic-assisted surgery system for minimally invasive urologic surgical procedures via the 510(k) pathway. The system launched on the US market following clearance, expanding competition in the robotic surgery sector dominated by Intuitive Surgical's da Vinci.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures
https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures
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Details
Incident Context & FAQ
What happened in FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures?
On December 3, 2025, the FDA cleared Medtronic's Hugo robotic-assisted surgery system for minimally invasive urologic surgical procedures via the 510(k) pathway. The system launched on the US market following clearance, expanding competition in the robotic surgery sector dominated by Intuitive Surgical's da Vinci.
When did this incident occur?
The incident is recorded as occurring on December 3, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.
What robot was involved in FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures?
Hugo RAS by Medtronic is the recorded robot involved in this incident at Dublin, Ireland.
Has anyone responded to FDA clears Medtronic Hugo robotic-assisted surgery system for urologic 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 FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.