FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures
[REGULATORY ACTION]Jul 1, 2026 · CMR Surgical · Versius · India
Failure Mode
REGULATORY ACTION
Event Date
Jul 1, 2026
Primary Entity
CMR Surgical
Robotic Platform
Versius
Jurisdiction / Location
India
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
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.
System & Fleet Architecture
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.medicaldevice-network.com/news/fda-clears-cmr-surgical-versius-plus-robot/
https://www.medicaldevice-network.com/news/fda-clears-cmr-surgical-versius-plus-robot/
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Details
Incident Context & FAQ
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.
What robot was involved in FDA clears CMR Surgical Versius Plus robotic surgical system for gallbladder removal procedures?
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 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.