510(k) · Decided
Recalled · 2009Protege GPS Self-Expanding Nitinol Stent and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ev3, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Nov 21, 2003 after a 37-day review. The FDA summary names its predicate without a number. It has been recalled 11 times.
- Decided
- Nov 21, 2003
- Review
- 37 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 11
- Predicates
- 0
The FDA summary names its predicate without a number.
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FGE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FGE device
- #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | currently marketed stent and delivery system Named without a submission number |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 10, 2009 | Not classified | Z-2024-2009 | Labeling mix-ups | 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 product was labeled as a 6mm x 80mm… |
| Jun 10, 2009 | Not classified | Z-2025-2009 | Labeling mix-ups | 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 product was labeled as a 6mm x 80mm… |
| Jun 10, 2009 | Not classified | Z-2022-2009 | Labeling mix-ups | 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 product was labeled as a 6mm x 80mm… |
| Jun 10, 2009 | Not classified | Z-2023-2009 | Labeling mix-ups | 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 product was labeled as a 6mm x 80mm… |
| Dec 6, 2006 | Not classified | Z-0389-2007 | Other | 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 | Other | 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 | Other | 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 | Other | 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 | Other | 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 of a sealed inner tray in a sealed… |
| Jul 9, 2004 | Not classified | Z-1330-04 | Other | 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 (.035') stent system and that 6Fr 120… |
| Jul 9, 2004 | Not classified | Z-1329-04 | Other | 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 (.035') stent system and that 6Fr 120… |
The 5 latest of 11 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FGE devicesFGE Stents, Drains And Dilators For The Biliary Ducts: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FGE
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FGE
1,923in 2025
MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 316 | 54 | 1,006 |
| 2008 | 11 | 214 | 93 | 1,465 |
| 2009 | 7 | 160 | 18 | 1,655 |
| 2010 | 9 | 81 | 32 | 1,434 |
| 2011 | 9 | 114 | 2 | 1,321 |
| 2012 | 8 | 96 | 4 | 1,183 |
| 2013 | 5 | 161 | 3 | 1,060 |
| 2014 | 8 | 156 | 0 | 1,270 |
| 2015 | 8 | 79 | 0 | 1,543 |
| 2016 | 4 | 49 | 0 | 1,453 |
| 2017 | 9 | 59 | 1 | 1,515 |
| 2018 | 7 | 215 | 43 | 1,681 |
| 2019 | 2 | — | 13 | 1,896 |
| 2020 | 4 | 121 | 1 | 2,182 |
| 2021 | 1 | — | 27 | 2,297 |
| 2022 | 6 | 101 | 21 | 1,749 |
| 2023 | 6 | 199 | 19 | 1,615 |
| 2024 | 6 | 188 | 1 | 1,948 |
| 2025 | 7 | 257 | 0 | 1,923 |
| 2026 | 8 | 153 | 11 | — |
What is it indicated for?
The ev3 Protégé® GPS™ Self-Expanding Nitinol Stent and Delivery System is intended as a palliative treatment for malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033314 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033314: Protege GPS Self-Expanding Nitinol Stent and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033314
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026