K252111 is an FDA 510(k) clearance for the Versius Surgical System (Versius Plus). This device is classified as a Modular Electromechanical Surgical System (Class II - Special Controls, product code SCV).
Submitted by Cmr Surgical Limited (Cambridge, GB). The FDA issued a Cleared decision on December 16, 2025, 162 days after receiving the submission on July 7, 2025.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4964. A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures..
| 510(k) Number | K252111 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2025 |
| Decision Date | December 16, 2025 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | SCV — Modular Electromechanical Surgical System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.4964 |
| Definition | A Modular Electromechanical Surgical System Is A Software-controlled Electromechanical System With A Plurality Of Individual, Fully Positionable Patient/device Interfaces Which Allows A Qualified User To Perform Surgical Techniques During Minimally Invasive Surgical Procedures. |