# K250725: Hugo™ RAS System

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, LLC
- Decided: Dec 3, 2025 after 268 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
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 7.

## Indications for use
The Hugo™ Robotically Assisted Surgery (RAS) System is intended to assist in the accurate control of instruments and accessories including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/graspers, needle holders, electrosurgical tools and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrosurgery, and suturing during minimally invasive urologic surgical procedures. The system is indicated for adult use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative surgical procedures set forth in the Hugo™ RAS System Indications Document.

Source page: https://510kreport.com/device/K250725
Methodology: https://510kreport.com/methodology