# K042204: Modification to Protege GPS Self-Expanding Nitinol Stent

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Aug 23, 2004 after 7 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
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) currently marketed stent and delivery system: named in the summary without a submission number

## Most influential descendants
- K060487: Lifestent Flexstar XL Biliary Stent System (2006), 1 descendant of its own
- K130792: Lifestent Biliary Stent System, Lifestent XL Biliary Stent System (2013), 0 descendants of its own

## Indications for use
The Prot6g6® GPS[M Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K042204
Methodology: https://510kreport.com/methodology