Cmr Surgical Limited · Class II · Cleared Dec 16, 2025
| K-number | K252111 |
| Device name | Versius Surgical System (Versius Plus) |
| Applicant | Cmr Surgical Limited |
| Product code | SCV |
| Device class | Class II |
| Decision date | Dec 16, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 878.4964 |
The Versius Surgical System (Versius Plus) is a robotically assisted surgical device that enables surgeons to control endoscopic instruments for minimally invasive procedures. It consists of a surgeon console, bedside units with visualization and instrument arms, detachable surgical instruments, and support equipment. The device is indicated for adult patients 22 years and older undergoing soft tissue minimal access surgery, specifically cholecystectomy.
Key changes from the predicate device include: addition of near-infrared (NIR) imaging capability with dual image sensors in the endoscopic camera; updated software version with improved user interface, robotic control, and NIR light source communication support; three new surgical instruments (Cadiere Grasper with shorter jaw design, Monopolar Curved Scissors with insulating sleeve, and Bipolar Fenestrated Grasper); and material changes to five existing instruments to support increased reuse cycles, higher RF voltage, and volume manufacturability.
Not stated in this summary. The document references applicable performance and safety requirements for reprocessing, biocompatibility, sterility, packaging, software, cybersecurity, mechanical, electrical and electrosurgical performance, electromagnetic compatibility, electrical safety (60601-1), reliability, and human factors, but does not cite specific consensus standards by designation.
The subject device has identical intended use and indications for use as the predicate device (cholecystectomy in adults 22 and older). Testing demonstrates the subject device performs as well or better than the predicate, and the technological changes (NIR capability, software updates, new instruments, and material modifications) do not raise different questions of safety or effectiveness. Human factors validation and preclinical porcine model testing confirm safe and effective use with the new NIR capability using an equivalent approach to a reference device (Richard Wolf System Green K212808).
View the full FDA submission: accessdata.fda.gov