510(k) · Decided
DecidedZilver Biliary Stent System Usw
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 Jul 2, 2004 as substantially equivalent to K020788 (Wilson-Cook Medical, Inc., 2002) after an 84-day review. Its family tree reaches back 2 generations to 2001. 24 later devices descend from it.
- Decided
- Jul 2, 2004
- Review
- 84 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K010242 (2001). 24 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK010242 Cook Zilver Biliary StentCook, Inc. · 2001
- 1 generation backK020788 Wilson-Cook Zilver Biliary StentWilson-Cook Medical, Inc. · 2002 · Recalled
- This deviceK040930 Zilver Biliary Stent System UswWilson-Cook Medical, Inc. · 2004
- Descendant · cites it directly · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · 2 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- Descendant · 3 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 6 of its ownK111149 Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011
- Descendant · 3 generations on · 3 of its ownK211706 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · cites it directly23descendants
- K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 2 generations on10descendants
- K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 3 generations on9descendants
- K111149Hanarostent Biliary (NNN)M.I.Tech Co., Ltd. · 2011 · 2 generations on6descendants
- K211706Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K010242 | Cook Zilver Biliary Stent | Cook, Inc. | 2001 | — |
| −1 | K020788 | Wilson-Cook Zilver Biliary Stent | Wilson-Cook Medical, Inc. | 2002 | 3 |
| 0 (this device) | K040930 | Zilver Biliary Stent System Usw | Wilson-Cook Medical, Inc. | 2004 | — |
| +1 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +2 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| +3 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| +2 | K111149 | Hanarostent Biliary (NNN) | M.I.Tech Co., Ltd. | 2011 | — |
| +3 | K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K020788 | Wilson-Cook Zilver Biliary StentSummary page 1…, GUI 78 FGE Classification: 21 CFR § 876.501 0 PREDICATE DEVICES: Wilson-Cook Zilver Biliary Stent (k020788) INTENDED USE: Wilson-Cook's Zilvec Biliary Stent System-USW… | 2002 |
What descends from it? (24)
See all 241 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073667 | Niti-S Biliary Stent | 2008 | 23 |
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 3 years and passes through 2 companies; a new generation was cleared every 2.2 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K073667 (Taewoong Medical Co., Ltd., 2008) has gone furthest, with 23 descendants of its own.
- 3 other devices also cite its predicate K020788.
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 System USE is indicated for the palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040930 · printed Nov 4, 2026
Cite this page
510(k) Report. “K040930: Zilver Biliary Stent System Usw.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K040930
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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