CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery
[REGULATORY ACTION]Mar 15, 2026 · CMR Surgical · Versius · India
Failure Mode
REGULATORY ACTION
Event Date
Mar 15, 2026
Primary Entity
CMR Surgical
Robotic Platform
Versius
Jurisdiction / Location
India
Audit Standard
Physical State Verified
Incident Abstract & Audit Findings
CMR Surgical received FDA 510(k) clearance for its Versius Plus second-generation robotic surgical platform for gallbladder surgery, on track for US commercialization in 2026.
System & Fleet Architecture
Operating Manufacturer
Hardware Platform
Operational Sectors
Primary Sources & Evidentiary Filings
- Inspect Filing
https://www.mddionline.com/robotics/fda-clears-new-robotic-platform-for-gallbladder-surgery
https://www.mddionline.com/robotics/fda-clears-new-robotic-platform-for-gallbladder-surgery
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Details
Incident Context & FAQ
What happened in CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?
CMR Surgical received FDA 510(k) clearance for its Versius Plus second-generation robotic surgical platform for gallbladder surgery, on track for US commercialization in 2026.
When did this incident occur?
The incident is recorded as occurring on March 15, 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 CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?
Versius by CMR Surgical is the recorded robot involved in this incident at India.
Has anyone responded to CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?
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 CMR Surgical Versius Plus receives FDA 510(k) clearance for gallbladder surgery?
This incident is an active record on the DEPLOY registry; no retraction or correction has been issued.