_Incident · Regulatory action_

# CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery

Canonical ID: `3c60a7c7-e7f3-4602-85de-abae3fa4ebac`

- **Occurred:** 2026-03-15
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [CMR Surgical](/companies/cmr-surgical.md) (id: `6bbb447e-0278-4ae1-822d-8b546420511e`)

CMR Surgical received FDA 510(k) clearance for its Versius Plus second-generation robotic surgical platform for gallbladder surgery, on track for US commercialization in 2026.

## Sources (1)

1. https://www.mddionline.com/robotics/fda-clears-new-robotic-platform-for-gallbladder-surgery

## Status history

- **active** · 2026-07-08 · agent:depth

## Common questions

### What happened in CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?

CMR Surgical received FDA 510(k) clearance for its Versius Plus second-generation robotic surgical platform for gallbladder surgery, on track for US commercialization in 2026.

### When did this incident occur?

The incident is recorded as occurring on March 15, 2026 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

### Who was involved in CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?

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

### Has anyone responded to CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?

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 CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?

This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.


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