_Incident · Regulatory action_

# FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy

Canonical ID: `7c96ee5c-2bb2-4613-9195-d3b7b2bae795`

- **Occurred:** 2025-12-16
- **Kind:** `regulatory_action`
- **Status (derived):** active
- **Company:** [CMR Surgical](/companies/cmr-surgical.md) (id: `6bbb447e-0278-4ae1-822d-8b546420511e`)

The FDA cleared [CMR Surgical](/companies/cmr-surgical.md)'s Versius Plus minimally invasive robotic surgical system via the 510(k) pathway (K252111), with a decision date of December 16, 2025. The system is indicated for gallbladder removal (cholecystectomy) and features a modular design for portability between hospital departments. CMR plans to begin US commercialization in 2026.

## Sources (1)

1. **FDA** · https://www.accessdata.fda.gov/cdrh_docs/pdf25/K252111.pdf · 2025-12-16

## Status history

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

## Common questions

### What happened in FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy?

The FDA cleared CMR Surgical's Versius Plus minimally invasive robotic surgical system via the 510(k) pathway (K252111), with a decision date of December 16, 2025. The system is indicated for gallbladder removal (cholecystectomy) and features a modular design for portability between hospital departments. CMR plans to begin US commercialization in 2026.

### When did this incident occur?

The incident is recorded as occurring on December 16, 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 CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy?

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 via 510(k) for cholecystectomy?

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 via 510(k) for cholecystectomy?

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


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