De Novo · Granted
GrantedWallFlex Biliary RX Fully Covered Stent System RMV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific · PNB Biliary Stent System For Benign Strictures
Granted on Jun 3, 2016 as a new device type through De Novo after a 280-day review. 2 later devices descend from it.
- Decided
- Jun 3, 2016
- Review
- 280 days
- Class
- Class II
- Product code
- PNB
- Recalls
- None
2 later devices descend from it, 1 citing it directly.
- This deviceDEN150040 WallFlex Biliary RX Fully Covered Stent System RMVBoston Scientific · 2016
- Descendant · cites it directly · 1 of its ownK240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System…Boston Scientific · 2024
- Descendant · 2 generations on · 0 of its ownK242950 WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150040 | WallFlex Biliary RX Fully Covered Stent System RMV | Boston Scientific | 2016 | — |
| +1 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary… | Boston Scientific | 2024 | — |
| +2 | K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
Sources: FDA De Novo 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 PNB? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully… | 2024 | 1 |
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, K240464 (Boston Scientific, 2024) has gone furthest, with 1 descendant of its own.
How does its category compare?
All PNB devicesPNB Biliary Stent System For Benign Strictures: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PNB
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · PNB
Too few PNB 510(k)s in any year since 2007 to give a median.
Recalls per year · PNB
No recall names PNB since 2007.
Adverse event reports per year · PNB
36in 2025
MAUDE reports naming product code PNB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 22 |
| 2018 | 0 | — | 0 | 48 |
| 2019 | 0 | — | 0 | 46 |
| 2020 | 0 | — | 0 | 48 |
| 2021 | 0 | — | 0 | 29 |
| 2022 | 0 | — | 0 | 16 |
| 2023 | 0 | — | 0 | 27 |
| 2024 | 0 | — | 0 | 39 |
| 2025 | 0 | — | 0 | 36 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
indicated for indwell up to 12 months in the treatment of benign biliary strictures secondary to chronic pancreatitis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150040 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN150040: WallFlex Biliary RX Fully Covered Stent System RMV.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN150040
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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