510(k) · Decided
DecidedWallstent Biliary Endoprosthesis and Unistep Plus Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Scimed, Inc. · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 30, 1999 as substantially equivalent to K964119 (Boston Scientific Scimed, Inc., 1997) after a 94-day review. Its family tree reaches back 3 generations to 1991. 14 later devices descend from it.
- Decided
- Dec 30, 1999
- Review
- 94 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K911292 (1991). 5 ancestors in all. 14 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 2 generations backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- 1 generation backK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997 · Recalled
- This deviceK993232 Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999
- Descendant · cites it directly · 10 of its ownK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- Descendant · 2 generations on · 7 of its ownK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- Descendant · 2 generations on · 6 of its ownK083374 Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 2009
- Descendant · 2 generations on · 6 of its ownK083627 Wallflex Biliary RX Fully-Covered Stent System, Model…Boston Scientific Corporation · 2009
- Descendant · cites it directly · 5 of its ownK112543 Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex…Boston Scientific Corporation · 2011
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K061231Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006 · cites it directly10descendants
- K08173310MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Boston Scientific Corp · 2008 · 2 generations on7descendants
- K083374Wallflex Biliary RX Partially-Covered Stent SystemBoston Scientific Corp · 2009 · 2 generations on6descendants
- K083627Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Boston Scientific Corporation · 2009 · 2 generations on6descendants
- K112543Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic…Boston Scientific Corporation · 2011 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −2 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| −1 | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | 6 |
| 0 (this device) | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Scimed, Inc. | 1999 | — |
| +1 | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
| +2 | K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 | Boston Scientific Corp | 2008 | — |
| +2 | K083374 | Wallflex Biliary RX Partially-Covered Stent System | Boston Scientific Corp | 2009 | — |
| +2 | K083627 | Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510… | Boston Scientific Corporation | 2009 | — |
| +1 | K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary… | Boston Scientific Corporation | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2023 | 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? (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 |
|---|---|---|---|
| * | K964119 | Wallstent Transhepatic Biliary EndoprosthesisSummary page 1…Unistep™ Plus Delivery System Common Name Biliary Stent Classification Class II Predicate Devices WALLSTENT® Biliary Endoprosthesis with Unistep™ Plus Delivery System - K964119 Device Description 'The WALLSTEN1® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy a… | 1997 |
What descends from it? (14)
See all 144 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061231 | Wellflex Biliary RX Stent System | 2006 | 10 |
| K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic… | 2011 | 5 |
| K012822 | Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model… | 2001 | 1 |
| K152853 | WALLSTENT RP Endoprosthesis Transhepatic Biliary, WALLSTENT Endoprosthesis Transhepatic… | 2015 | 0 |
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 8 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K061231 (Boston Scientific Corp, 2006) has gone furthest, with 10 descendants of its own.
- 7 other devices also cite its predicate K964119.
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 Wallstent® Biliary Endoprosthesis is indicated for 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/K993232 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993232: Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993232
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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