# K033314: Protege GPS Self-Expanding Nitinol Stent and Delivery System

- Pathway: 510(k) (Special)
- Applicant: Ev3, Inc.
- Decided: Nov 21, 2003 after 37 days
- Product code: FGE (Stents, Drains And Dilators For The Biliary Ducts)
- Device class: 2
- Regulation: 21 CFR 876.5010
- Recalls of this device: 11 (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
- Jun 10, 2009 · Not classified · Z-2024-2009: ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected pr
- Jun 10, 2009 · Not classified · Z-2025-2009: ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected pr
- Jun 10, 2009 · Not classified · Z-2022-2009: ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected pr
- Jun 10, 2009 · Not classified · Z-2023-2009: ev3 Inc. is conducting a voluntary recall of specific lots of the Protege GPS Self-Expanding Stent System because labeling did not match the actual stent size contained in the package. The affected pr
- Dec 6, 2006 · Not classified · Z-0389-2007: Two individual ev3 Protege GPS Biliary Stent System devices were incorrectly labeled as SERB65-09-60-120 and the actual device is SERB65-12-60-80. Length is shorter than expected.
- Jun 10, 2005 · Not classified · Z-0935-05: A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Jun 10, 2005 · Not classified · Z-0934-05: A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Jun 10, 2005 · Not classified · Z-0936-05: A total of 3 devices from 3 separate lots were re-labeled with incorrect stent dimensions (diameter and length) and distributed to 2 hospitals. Affected product was retrieved by an ev3 representative.
- Sep 1, 2004 · Not classified · Z-0008-05: A customer complaint received indicated that a Protg stent, PN SERB65-09-30-120 was found in a pouch that was not properly sealed. The Protg GPS Stent System is 'double barrier' packaged and consists 
- Jul 9, 2004 · Not classified · Z-1330-04: Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (
- Jul 9, 2004 · Not classified · Z-1329-04: Ev3 had received customer complaints indicating that the stent device could not be used with an .035' guidewire. An investigation found that 6Fr, 135 cm (.018') stent system were labeled as a 120 cm (

## Indications for use
The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.

Source page: https://510kreport.com/device/K033314
Methodology: https://510kreport.com/methodology