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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 · Versius at India · CMR Surgical · India · Surgical robots · Investigated by FDA

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Incident records on DEPLOY are compiled from public sources (regulatory filings, news reports, and operator disclosures) and reflect what has been reported and tracked to date. They are not legal findings, determinations of fault, or safety ratings, and may be updated as new information is verified. See the sources below for the underlying references.
Track FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))

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Sources (1)

  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.
What robot was involved in FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))?
Versius by CMR Surgical is the recorded robot involved in this incident at India.
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: Verified · 1 source (no primary) · last reviewed 2026-07-14

Verification posture

Verified

Low confidence

Review state

Stable

Last reviewed 2026-07-14

Sources by quality tier

1
unclassified
Unclassified source

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

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

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