# K050725: Protege GPS Self-Expanding Nitinol Stent

- Pathway: 510(k) (Special)
- Applicant: Ev3 Corporation
- Decided: Apr 20, 2005 after 30 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 1 (0 Class I)
- 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. 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

## Recalls of this device
- Oct 30, 2010 · Not classified · Z-0626-2011: Mislabeled size: Specific Protg GPS lots have product labeling that does not match the actual stent sizes contained in the packages. The affected product outer packaging is labeled as a 12 mm x 60 mm 

## Indications for use
The Prot~gd® GPS TM Self-Expanding Nitinol Stent is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.

Source page: https://510kreport.com/device/K050725
Methodology: https://510kreport.com/methodology