# K252111: Versius Surgical System (Versius Plus)

- Pathway: 510(k) (Traditional)
- Applicant: Cmr Surgical Limited
- Decided: Dec 16, 2025 after 162 days
- Product code: SCV (Modular Electromechanical Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4964
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230078 (2024). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230078: Versius Surgical System, Cmr Surgical Limited (2024) Summary page 5.

## Recalls of this device
- Jun 9, 2026 · Class II · Z-2717-2026: Secure Boot was mistakenly not enabled at manufacturing time, which presents a potential cybersecurity risk.

## Indications for use
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, scissors, 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. The Versius Surgical System is indicated for adult patients 22 years of age and older, eligible for soft tissue minimal access surgery, for cholecystectomy.

Source page: https://510kreport.com/device/K252111
Methodology: https://510kreport.com/methodology