510(k) Report

510(k) · Decided

Recalled · 2010

Protege Everflex Self-Expanding Biliary Stent System

K060057510(k) SpecialDecided Mar 8, 200658-day reviewClass II21 CFR 876.5010Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Ev3, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts

Cleared on Mar 8, 2006 after a 58-day review. The FDA summary names its predicate without a number. 7 later devices descend from it. It has been recalled 2 times.

Decided
Mar 8, 2006
Review
58 days
Class
Class II
Product code
FGE
Recalls
2
Predicates
0

7 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2012: 2 descendants cleared2008: 2 descendants cleared2026: 1 descendant cleared2011: 1 descendant cleared2013: 1 descendant cleared20052010201520202025
  1. This deviceK060057 Protege Everflex Self-Expanding Biliary Stent SystemEv3, Inc. · 2006
  2. Descendant · cites it directly · 4 of its ownK062798 Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB…Cordis Corp. · 2008 · Recalled
  3. Descendant · 2 generations on · 2 of its ownK111766 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic…Idev Technologies, Inc. · 2011 · Recalled
  4. Descendant · cites it directly · 2 of its ownK072301 5MM Protege Everflex Self Expanding Biliary Stent System, Model…Ev3, Inc. · 2008
  5. Descendant · 3 generations on · 1 of its ownK122546 Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic…Idev Technologies, Inc. · 2012
  6. Descendant · cites it directly · 0 of its ownK262913 Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2008: 22011: 12012: 22013: 12026: 1
2008high 2 (2008) · low 0 (2009)2026

Most influential descendants

Showing 5 of 7 · See all
  • K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp. · 2008 · cites it directly4descendants
  • K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary SystemsIdev Technologies, Inc. · 2011 · 2 generations on2descendants
  • K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc. · 2008 · cites it directly2descendants
  • K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc. · 2012 · 3 generations on1descendant
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K060057Protege Everflex Self-Expanding Biliary Stent SystemEv3, Inc.2006—
+1K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB…Cordis Corp.20082
+2K111766Supera Veritas Interwoven Self-Expanding Nitinol Stent Transheptic Biliary…Idev Technologies, Inc.20111
+1K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc.2008—
+3K122546Supera Veritas Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary…Idev Technologies, Inc.2012—
+1K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200820
201110
201220
201310
202610
FIG. 1 — Lineage of K060057, 2006–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K240464 WallFlex Biliary RX Stent System; Epic Biliary…score 14.5 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Protege EverFlex Self-Expanding Biliary Stent System
Named without a submission number
—

What descends from it? (7)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K062798Smart Nitinol Self-Expanding Stent, Model C06120MB, C07120MB, C08120MB, C06150MB…Cordis Corp.20084
K0723015MM Protege Everflex Self Expanding Biliary Stent System, Model PRP35-05Ev3, Inc.20082
K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc.20260
K111627Supera Veritas (R) Interwoven Self-Expanding Nitinol Stent Transhepatic Biliary SystemIdev Technologies, Inc.20120

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Mar 31, 2010Not classifiedZ-1598-2010Mixed-up of materials/componentsev3 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-Expanding stent and two lots o 150mm…
Nov 6, 2009Not classifiedZ-0478-2010Labeling mix-upsev3 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 length of the target lesion and may…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K062798 (Cordis Corp., 2008) has gone furthest, with 4 descendants of its own.

How does its category compare?

All FGE devices

FGE 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

2007: 42008: 112009: 72010: 92011: 92012: 82013: 52014: 82015: 82016: 42017: 92018: 72019: 22020: 42021: 12022: 62023: 62024: 62025: 72026 (partial year): 8
2007high 11 (2008) · low 1 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FGE

257in 2025

2007: 316 days median2008: 214 days median2009: 160 days median2010: 81 days median2011: 114 days median2012: 96 days median2013: 161 days median2014: 156 days median2015: 79 days median2016: 49 days median2017: 59 days median2018: 215 days median2020: 121 days median2022: 101 days median2023: 199 days median2024: 188 days median2025: 257 days median2026 (partial year): 153 days median
2007high 316 (2007) · low 49 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FGE

1in 2024

2007: 542008: 932009: 182010: 322011: 22012: 42013: 32017: 12018: 432019: 132020: 12021: 272022: 212023: 192024: 12026 (partial year): 11
2007high 93 (2008) · low 0 (2014)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FGE

1,923in 2025

2007: 1,0062008: 1,4652009: 1,6552010: 1,4342011: 1,3212012: 1,1832013: 1,0602014: 1,2702015: 1,5432016: 1,4532017: 1,5152018: 1,6812019: 1,8962020: 2,1822021: 2,2972022: 1,7492023: 1,6152024: 1,9482025: 1,923
2007high 2,297 (2021) · low 1,006 (2007)2025

MAUDE reports naming product code FGE, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074316541,006
200811214931,465
20097160181,655
2010981321,434
2011911421,321
201289641,183
2013516131,060
2014815601,270
201587901,543
201644901,453
201795911,515
20187215431,681
20192—131,896
2020412112,182
20211—272,297
20226101211,749
20236199191,615
2024618811,948
2025725701,923
2026815311—

What is it indicated for?

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

Indications for use as stated in the FDA summary.

More from Ev3, Inc.

35 FDA decisions under this applicant name. See the company

  • K141118Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation CatheterEv3, Inc. · 20141 recall
  • K132777Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation CatheterEv3, Inc. · 2013
  • K130911Rapidcross Pta Rapid Exchange Balloon Dilatation CatheterEv3, Inc. · 2013
  • K123544Rapidcross Pta Rapid Exchange, Balloon Dilatation CatheterEv3, Inc. · 2013
  • K111723Turbohawk Peripheral Plaque Excision SystemEv3, Inc. · 20111 recall

Recent decisions in FGE

The FGE category page

  • K254179Drainage CatheterCanyon Medical, Inc. · 2026
  • K262913Protégé™ EverFlex™ Self-expanding Peripheral Stent SystemMedtronic, Inc. · 2026
  • K260835ARCHIMEDES Biodegradable Stent (Medium)Q3 Medical USA, LLC (C/O Q3 Medical Devices Ltd.) · 2026
  • K253393Single-use Balloon Dilatation Catheter (AG-5251-083018 AG-5251-085518 AG-5251-088018 AG-5251-083019…Hangzhou AGS MedTech Co., Ltd. · 2026
  • K253832Dilation Balloon CatheterMirco-Tech (Nanjing) Co., Ltd. · 2026

https://510kreport.com/device/K060057 · printed Nov 5, 2026

Cite this page

510(k) Report. “K060057: Protege Everflex Self-Expanding Biliary Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K060057

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026