# K060057: Protege Everflex Self-Expanding Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Mar 8, 2006 after 58 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 4 cite it directly.
0 of 8 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) Protege EverFlex Self-Expanding Biliary Stent System: named in the summary without a submission number

## Most influential descendants
- K062798: Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB (2008), 4 descendants of its own
- K111766: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary Systems (2011), 2 descendants of its own
- K072301: 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 (2008), 2 descendants of its own
- K122546: Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary System (2012), 1 descendant of its own
- K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System (2026), 0 descendants of its own

## Recalls of this device
- Mar 31, 2010 · Not classified · Z-1598-2010: ev3 is conducting a voluntary recall on three lots of the Protg EverFlex" Biliary Stent System. They determined that a lot of 120mm Protg EverFlex" Biliary Stent system may contain a 150mm length Self
- Nov 6, 2009 · Not classified · Z-0478-2010: ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full l

## Indications for use
The Prot6g&® EverFlexTM Self-Expanding Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.

Source page: https://510kreport.com/device/K060057
Methodology: https://510kreport.com/methodology