510(k) · Decided
DecidedModification to Zilver 635 Biliary Stent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Aug 1, 2008 after a 207-day review. The FDA summary names no predicate by number. 4 later devices descend from it.
- Decided
- Aug 1, 2008
- Review
- 207 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK080037 Modification to Zilver 635 Biliary StentCook, Inc. · 2008
- Descendant · cites it directly · 3 of its ownK163018 Zilver 635 Biliary StentCook Ireland, Ltd. · 2016
- Descendant · 2 generations on · 2 of its ownK171809 Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation · 2017
- Descendant · 3 generations on · 1 of its ownK240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System…Boston Scientific · 2024
- Descendant · 4 generations on · 0 of its ownK242950 WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024
Most influential descendants
Showing 4 of 4 · See all- K163018Zilver 635 Biliary StentCook Ireland, Ltd. · 2016 · cites it directly3descendants
- K171809Epic Biliary Endoscopic Stent SystemBoston Scientific Corporation · 2017 · 2 generations on2descendants
- K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific · 2024 · 3 generations on1descendant
- K242950WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K080037 | Modification to Zilver 635 Biliary Stent | Cook, Inc. | 2008 | — |
| +1 | K163018 | Zilver 635 Biliary Stent | Cook Ireland, Ltd. | 2016 | — |
| +2 | K171809 | Epic Biliary Endoscopic Stent System | Boston Scientific Corporation | 2017 | — |
| +3 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary… | Boston Scientific | 2024 | — |
| +4 | K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2024 | 2 | 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?
The FDA summary names no predicate by number.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163018 | Zilver 635 Biliary Stent | 2016 | 3 |
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?
- Of its descendants, K163018 (Cook Ireland, Ltd., 2016) has gone furthest, with 3 descendants of its own.
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. 2008, 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 Zilver® 635 TM Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K080037: Modification to Zilver 635 Biliary Stent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K080037
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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