510(k) · Cleared
ClearedProtégé™ EverFlex™ Self-expanding Peripheral Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtronic, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Sep 17, 2026 as substantially equivalent to K060057 (Ev3, Inc., 2006) and 1 other predicate after a 29-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 17, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K964688 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK964688 Long Medium Palmaz-Schatz Balloon Expandable StentCordis Corp. · 1997
- 3 generations backK030053 Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680…Jomed AG · 2003
- 2 generations backK033537 Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005…Abbott Laboratories · 2003
- 1 generation backK072301 5MM Protege Everflex Self Expanding Biliary Stent System, Model…Ev3, Inc. · 2008
- This deviceK262913 Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964688 | Long Medium Palmaz-Schatz Balloon Expandable Stent | Cordis Corp. | 1997 | — |
| −3 | K030053 | Jostent Selfx, Models 015SX4406; 015SX4408; 015SX4410; 015SX680; 015SX6808… | Jomed AG | 2003 | — |
| −2 | K033537 | Selfx Xpert Biliary Stent, Models EX8L2005, EX8L3005, EX8L4005, EX8L2006… | Abbott Laboratories | 2003 | — |
| −1 | K072301 | 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05 | Ev3, Inc. | 2008 | — |
| 0 (this device) | K262913 | Protégé™ EverFlex™ Self-expanding Peripheral Stent System | Medtronic, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
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? (2)
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 |
|---|---|---|---|
| * | K060057 | Protege Everflex Self-Expanding Biliary Stent SystemSummary page 5…e FGE Predicate Device Device Trade name Protégé™ EverFlex™ Self-expanding Biliary Stent System 510(K) Number / Clearance Date K060057 / 08-Mar-2006 K072301 / 18-Mar-2008 Device Description The Protégé EverFlex self-expanding… | 2006 |
| * | K072301 | 5MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Summary page 5…Protégé™ EverFlex™ Self-expanding Biliary Stent System 510(K) Number / Clearance Date K060057 / 08-Mar-2006 K072301 / 18-Mar-2008 Device Description The Protégé EverFlex self-expanding peripheral stent system is a self-expanding Nitinol stent… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- 2 of the 10 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060057.
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. 2026, this device’s year, is highlighted.
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 stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K262913 · printed Nov 6, 2026
Cite this page
510(k) Report. “K262913: Protégé™ EverFlex™ Self-expanding Peripheral Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K262913
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026