_Incident · Regulatory action_

# FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures

Canonical ID: `86a754c6-f41a-4165-86e6-6c5b110ef5ab`

- **Occurred:** 2026-07-01
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [CMR Surgical](/companies/cmr-surgical.md) (id: `6bbb447e-0278-4ae1-822d-8b546420511e`)

[CMR Surgical](/companies/cmr-surgical.md) secured FDA 510(k) clearance for its Versius Plus minimally invasive robotic surgical system, indicated for gallbladder removal procedures. The modular system can be moved between hospital departments. CMR plans US commercialization in 2026, following a $200M equity and debt investment in April 2026.

## Sources (1)

1. **Medical Device Network** · https://www.medicaldevice-network.com/news/fda-clears-cmr-surgical-versius-plus-robot/ · 2026-07-01

## Status history

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

## Common questions

### What happened in FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures?

CMR Surgical secured FDA 510(k) clearance for its Versius Plus minimally invasive robotic surgical system, indicated for gallbladder removal procedures. The modular system can be moved between hospital departments. CMR plans US commercialization in 2026, following a $200M equity and debt investment in April 2026.

### When did this incident occur?

The incident is recorded as occurring on July 1, 2026 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 CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures?

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 FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal 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 CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures?

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


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