# K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: Sep 17, 2026 after 29 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K964688 (1997). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060057: Protege Everflex Self-Expanding Biliary Stent System, Ev3, Inc. (2006) Summary page 5.
- K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05, Ev3, Inc. (2008) Summary page 5.

## Indications for use
The stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K262913
Methodology: https://510kreport.com/methodology