SCV · Modular Electromechanical Surgical System
General, Plastic Surgery · 21 CFR 878.4964 · Class 2
Overview
| Product Code | SCV |
|---|---|
| Device Name | Modular Electromechanical Surgical System |
| Regulation | 21 CFR 878.4964 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
Identification
The Versius Surgical System is a robotically assisted surgical device that is intended to assist in the precise and accurate control of Versius Surgical endoscopic instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, forceps/pick-ups, needle holders, electrosurgery, and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery and suturing. It is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.
Classification Rationale
Class II (special controls). The device is a modular electromechanical surgical system subject to general controls and the identified special controls to mitigate risks such as electrical/mechanical fault, use error, infection, and adverse tissue reaction.
Special Controls
In combination with the general controls of the FD&C Act, the modular electromechanical surgical system is subject to the following special controls:
Cleared Devices (3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252111 | Versius Surgical System (Versius Plus) | Cmr Surgical Limited | Dec 16, 2025 | SESE |
| K250725 | Hugo RAS System | Covidien, LLC | Dec 3, 2025 | SESE |
| DEN230078 | Versius Surgical System | Cmr Surgical Limited | Oct 11, 2024 | DENG |
Top Applicants
- Cmr Surgical Limited — 2 clearances
- Covidien, LLC — 1 clearance
