Versius Plus
Second-generation modular surgical robot from CMR Surgical, cleared by the FDA in December 2025 under 510(k) K252111.
cmrsurgical.comAt a glance
- Type
- Device
- Who it’s for
- Clinicians and health systems
- Where it’s available
- United Kingdom, United States
- Sources cited
- 2
- In the library since
- 24 September 2026
- Regulatory status
- FDA 510(k) K252111, Versius Surgical System (Versius Plus), cleared 16 December 2025, product code SCV; the first-generation Versius holds De Novo DEN230078 (11 October 2024).As recorded from the regulator or the company, with its attribution.
What it does
CMR Surgical describes Versius Plus as designed to mimic the human arm, adding an ultrasonic dissector, integrated fluorescence visualisation (vLimeLite) and a 26-inch 3D HD screen to the Versius system, and says it is approved for use across Europe, Australia and Brazil.
Independent evidence
Established from a source other than the company.
The FDA cleared the Versius Surgical System (Versius Plus) under 510(k) K252111 on 16 December 2025, product code SCV; the first-generation Versius holds the De Novo DEN230078 of 11 October 2024.
Pricing is not published.
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