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Retracted · 2026-07-24

Duplicate ingestion of the same event as regulatory-action-2025-12-17-cmr-surgical, the canonical record for "CMR Versius Plus 510(k) (2025-12)". This duplicate is retracted to suppress it from aggregates; its own URL stays index,follow per the retraction fairness policy.

Incident · Regulatory action · Retracted

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

Original claim shown above is no longer asserted. See the retraction notice for context.

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.

Occurred 2025-12-16 · Versius at India · CMR Surgical · India · Surgical robots

How to read this record

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 robotic surgical system via 510(k) for cholecystectomy

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Sources (1)

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

Status history

  • Retracted · 2026-07-24

    Duplicate ingestion of the same event as regulatory-action-2025-12-17-cmr-surgical, the canonical record for "CMR Versius Plus 510(k) (2025-12)". This duplicate is retracted to suppress it from aggregates; its own URL stays index,follow per the retraction fairness policy.

  • 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. This incident was later retracted; see the retraction banner at the top of the page for the correction.
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.
What robot was involved in FDA clears CMR Surgical Versius Plus robotic surgical system via 510(k) for cholecystectomy?
Versius by CMR Surgical is the recorded robot involved in this incident at India.
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 retracted on the DEPLOY registry. The page remains so the correction reaches readers, but the incident is suppressed from aggregate counts (company / model / location) so it no longer counts against anyone.
Methodology: Verified · 1 source (1 primary) · last reviewed 2026-08-21

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-08-21

Sources by quality tier

1
primary-fda-database
FDA database

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

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

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