510(k) · Decided
Recalled · Class II · 2018Modification 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 Dec 29, 2004 after a 14-day review. The FDA summary names no predicate by number. 6 later devices descend from it. It has been recalled 28 times.
- Decided
- Dec 29, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 28
- Predicates
- 0
6 later devices descend from it, 2 citing it directly.
- This deviceK043481 Modification to: Zilver 635 Biliary StentCook, Inc. · 2004
- 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 · cites it directly · 1 of its ownK163169 Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentCook Ireland, Ltd. · 2017
- Descendant · 4 generations on · 0 of its ownK242950 WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
2016high 2 (2017) · low 0 (2019)2026
Most influential descendants
Showing 5 of 6 · 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
- K163169Zilver 518TM Biliary Stent; Zilver 635TM Biliary StentCook Ireland, Ltd. · 2017 · cites it directly1descendant
- 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) | K043481 | Modification to: Zilver 635 Biliary Stent | Cook, Inc. | 2004 | — |
| +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 | — |
| +1 | K163169 | Zilver 518TM Biliary Stent; Zilver 635TM Biliary Stent | Cook Ireland, Ltd. | 2017 | — |
| +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 | 2 | 0 |
| 2018 | 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? (6)
2 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 25, 2018 | Class II | Z-0327-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0329-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0339-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0325-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0336-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0338-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0345-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0346-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0348-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0349-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0350-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0326-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0330-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0334-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0341-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0342-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0352-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0324-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0328-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0331-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0332-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0333-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0335-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0337-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0340-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0343-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0344-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
| Sep 25, 2018 | Class II | Z-0347-2019 | Under Investigation by firm | The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail. |
The 5 latest of 28 recalls; the web page lists all.
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.
FDA decisions per year · FGE
7in 2025
2007high 11 (2008) · low 1 (2021)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FGE
257in 2025
2007high 316 (2007) · low 49 (2016)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FGE
1in 2024
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
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
| 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 Cook Zilver® 635 TM Biliary Stent is indicated for use in palliation of malignant neoplasms in the biliary tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043481: Modification to: Zilver 635 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/K043481
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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