510(k) · Decided
Recalled · 2008Wilson-Cook Zilver Biliary Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Wilson-Cook Medical, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on May 8, 2002 as substantially equivalent to K010242 (Cook, Inc., 2001) after a 58-day review. Its family tree reaches back 1 generation to 2001. 32 later devices descend from it. It has been recalled 3 times.
- Decided
- May 8, 2002
- Review
- 58 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 1 generation to K010242 (2001). 32 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK010242 Cook Zilver Biliary StentCook, Inc. · 2001
- This deviceK020788 Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. · 2002
- Descendant · cites it directly · 24 of its ownK040930 Zilver Biliary Stent System UswWilson-Cook Medical, Inc. · 2004
- Descendant · 2 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 3 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · 4 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- Descendant · 3 generations on · 6 of its ownK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K040930Zilver Biliary Stent System UswWilson-Cook Medical, Inc. · 2004 · cites it directly24descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 2 generations on23descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 3 generations on10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 4 generations on9descendants
- K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K010242 | Cook Zilver Biliary Stent | Cook, Inc. | 2001 | — |
| 0 (this device) | K020788 | Wilson-Cook Zilver Biliary Stent | Wilson-Cook Medical, Inc. | 2002 | — |
| +1 | K040930 | Zilver Biliary Stent System Usw | Wilson-Cook Medical, Inc. | 2004 | — |
| +2 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +3 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +4 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| +3 | K111149 | Hanarostent Biliary (NNN) | M.I.Tech Co., Ltd. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K010242 | Cook Zilver Biliary StentSummary page 1…The modification of the Zilver Biliary Stent includes a change to the introduction system only. The stent itself is identical to the predicate Cook Zilver Biliary Stent (K010242) in configuration and materials of coenstruction, and the intended use for both the predicate and modified device are also the sa… | 2001 |
What descends from it? (32)
See all 324 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 11, 2008 | Not classified | Z-0113-2009 | Process control | A section of the introduction system may detach after the stent has deployed. |
| Aug 21, 2002 | Not classified | Z-0089-04 | Other | Complaints were reported of difficulty in stent deployment. |
| Jan 8, 2002 | Not classified | Z-1181-03 | Other | The inner catheter of the introducer system may break after stent deployment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Wilson-Cook Zilver Biliary Stent is indicated for use in the palliation 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/K020788 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020788: Wilson-Cook Zilver Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020788
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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