Anovo Surgical System (6Ne)
Device Facts
| Record ID | K260804 |
|---|---|
| Device Name | Anovo Surgical System (6Ne) |
| Applicant | Momentis Surgical , Ltd. |
| Product Code | SCV · General, Plastic Surgery |
| Decision Date | Jul 22, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4964 |
| Device Class | Class 2 |
Regulatory Classification
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.
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:
