# K152933: Vesalius

- Pathway: 510(k) (Special)
- Applicant: Telea Electronic Engineering Srl
- Decided: Mar 23, 2016 after 170 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Vesalius Essential device and its accessories are intended for resection, ablation and coagulation of soft tissues and haemostasis of blood vessels in surgical procedures in orthopedic, arthroscopic, neurosurgery, ENT, and spinal procedures.

Source page: https://510kreport.com/device/K152933
Methodology: https://510kreport.com/methodology