FDA clears CMR Surgical Versius Plus surgical robotic platform for cholecystectomy (510(k))
[REGULATORY ACTION]Dec 17, 2025 · CMR Surgical · Versius · India
Failure Mode
REGULATORY ACTION
Event Date
Dec 17, 2025
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 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.
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 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.