# K061566: Primus GPS Biliary Stent System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Aug 31, 2006 after 86 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.
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 no predicate by number.

## Recalls of this device
- Jul 1, 2008 · Not classified · Z-1548-2008: ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.
- Jul 1, 2008 · Not classified · Z-1547-2008: ev3, Inc. has determined that specific lots of the Visi-Pro" BE Stent system may not have adequate securement of the stent to the delivery system and may have a larger diameter/profile than intended.

## Indications for use
The PRIMUSTM GPSTM Biliary Stent SystemTM is intended as a palliative treatment for malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K061566
Methodology: https://510kreport.com/methodology