_Incident · Regulatory action_

# FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures

Canonical ID: `7956afd2-8df9-410f-a639-a49083f48cb3`

- **Occurred:** 2025-12-03
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [Medtronic](/companies/medtronic.md) (id: `5ed6adff-c714-4880-bb1e-62af35017f4f`)

On December 3, 2025, the FDA cleared [Medtronic](/companies/medtronic.md)'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.

## Sources (1)

1. **Medtronic** · https://news.medtronic.com/2025-12-03-Medtronic-announces-FDA-clearance-of-Hugo-TM-robotic-assisted-surgery-system-for-urologic-surgical-procedures · 2025-12-03

## Status history

- **active** · 2026-07-23 · agent:recon

## Common questions

### 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.

### Who was involved in FDA clears Medtronic Hugo robotic-assisted surgery system for urologic procedures?

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

### 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.


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