# DEN230078: Versius Surgical System

- Pathway: De Novo (Direct)
- Applicant: Cmr Surgical Limited
- Decided: Oct 11, 2024 after 325 days
- Product code: SCV (Modular Electromechanical Surgical System)
- Device class: 2
- Regulation: 21 CFR 878.4964
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K260804: Anovo Surgical System (6Ne) (2026), 0 descendants of its own
- K252111: Versius Surgical System (Versius Plus) (2025), 0 descendants of its own
- K250725: Hugo™ RAS System (2025), 0 descendants of its own

## 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/DEN230078
Methodology: https://510kreport.com/methodology