When did this incident occur?

The incident is recorded as occurring on December 17, 2025 on the DEPLOY registry. The date reflects the underlying real-world event, not the registry record's creation date.

Incident · Regulatory action

FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))

CMR Surgical received FDA 510(k) clearance for its second-generation Versius Plus surgical robotic platform, covering cholecystectomy (gallbladder removal) procedures. The clearance follows FDA's de novo authorization of the first-generation Versius in October 2024. CMR plans U.S. commercialization in 2026.

Occurred 2025-12-17 · CMR Surgical

Track FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))

Machine-readable surfaces

Markdown mirror: /incidents/regulatory-action-2025-12-17-cmr-surgical.md
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REST API: /v1/incidents/6bda2e20-1939-473e-874a-709523d10d5f
Data documentation: /data
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Sources (1)

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

Status history

Active · 2026-07-06 · agent:depth

Common questions

What happened in FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))?: CMR Surgical received FDA 510(k) clearance for its second-generation Versius Plus surgical robotic platform, covering cholecystectomy (gallbladder removal) procedures. The clearance follows FDA's de novo authorization of the first-generation Versius in October 2024. CMR plans U.S. commercialization in 2026.
When did this incident occur?: The incident is recorded as occurring on December 17, 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 surgical robotic platform for cholecystectomy (510(k))?: 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 surgical robotic platform for cholecystectomy (510(k))?: 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 surgical robotic platform for cholecystectomy (510(k))?: This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.

Methodology: Unreviewed · 1 source (no primary) · last reviewed 2026-07-06

Verification posture

Unreviewed

Low confidence

Review state

Stable

Last reviewed 2026-07-06

Sources by quality tier

1: unclassified; Unclassified source

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

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Canonical ID 6bda2e20-1939-473e-874a-709523d10d5f