510(k) · Cleared
Recalled · 2006Wallstent Transhepatic Biliary Endoprosthesis
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 Apr 28, 1997 as substantially equivalent to K911292 (Pfizer Hospital Products Group, Inc., 1991) and 3 other predicates after a 195-day review. Its family tree reaches back 2 generations to 1991. 54 later devices descend from it. It has been recalled 6 times.
- Decided
- Apr 28, 1997
- Review
- 195 days
- Class
- Class II
- Product code
- FGE
- Recalls
- 6
- Predicates
- 4
Its longest line of descent runs back 2 generations to K911292 (1991). 4 ancestors in all. 54 later devices descend from it, 8 citing it directly.
- Root · 2 generations backK911292 Schneider Wallstent (R)Pfizer Hospital Products Group, Inc. · 1991
- 1 generation backK961262 Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic…Boston Scientific Scimed, Inc. · 1996
- This deviceK964119 Wallstent Transhepatic Biliary EndoprosthesisBoston Scientific Scimed, Inc. · 1997
- Descendant · cites it directly · 40 of its ownK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- Descendant · cites it directly · 37 of its ownK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- Descendant · 2 generations on · 23 of its ownK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- Descendant · cites it directly · 14 of its ownK993232 Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999
- Descendant · 2 generations on · 11 of its ownK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
Showing 5 of 54 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 54 · See all- K982184Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998 · cites it directly40descendants
- K012752Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · cites it directly37descendants
- K073667Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008 · 2 generations on23descendants
- K993232Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemBoston Scientific Scimed, Inc. · 1999 · cites it directly14descendants
- K030107100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MMBoston Scientific Corp · 2003 · 2 generations on11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K911292 | Schneider Wallstent (R) | Pfizer Hospital Products Group, Inc. | 1991 | — |
| −1 | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary… | Boston Scientific Scimed, Inc. | 1996 | — |
| 0 (this device) | K964119 | Wallstent Transhepatic Biliary Endoprosthesis | Boston Scientific Scimed, Inc. | 1997 | — |
| +1 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| +1 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| +2 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| +1 | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System | Boston Scientific Scimed, Inc. | 1999 | — |
| +2 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
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 |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 5 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 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? (4)
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 |
|---|---|---|---|
| * | K911292 | Schneider Wallstent (R)Summary page 1…is, MN 55442 (612) 550-5848 Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Biliary Transhepatic Endoprosthesis WALLSTENT® Biliary Endoscopic Endoprosthesis K911292, K914227, K923993, K961262 The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical supera… | 1991 |
| * | K914277 | Wallstent (R) Trans Biliary Endo W/Unistep Deliv SY Our OCR of the scanned summary read K914227, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “WALLSTENT® Biliary Endoscopic Endoprosthesis”. | 1991 |
| * | K923993 | Wallstent Biliary EndoprothesesSummary page 1…550-5848 Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Biliary Transhepatic Endoprosthesis WALLSTENT® Biliary Endoscopic Endoprosthesis K911292, K914227, K923993, K961262 The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elasto… | 1994 |
| * | K961262 | Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisSummary page 1…Cathy Yohnk Senior Regulatory Affairs Associate WALLSTENT® Biliary Transhepatic Endoprosthesis WALLSTENT® Biliary Endoscopic Endoprosthesis K911292, K914227, K923993, K961262 The WALLSTENT® Biliary Endoprosthesis is a self-expanding prosthesis constructed of biomedical superalloy and an elastomeric pol… | 1996 |
| † | K940396 | Wallstent Esophageal Prosthesis (Double) | 1994 |
What descends from it? (54)
See all 548 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982184 | Wallstent Endoprosthesis | 1998 | 40 |
| K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | 2001 | 37 |
| K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery System | 1999 | 14 |
| K061231 | Wellflex Biliary RX Stent System | 2006 | 10 |
| K980653 | Perflex Stainless Steel Stent and Delivery System | 1998 | 7 |
| K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic… | 2011 | 5 |
| K081956 | Medinol X-Suit Nir Biliary Metallic Stent | 2009 | 0 |
| K982005 | Wallstent Transhepatic Biliary Endoprosthesis | 1998 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 20, 2006 | Not classified | Z-0607-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Dec 20, 2006 | Not classified | Z-0609-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Dec 20, 2006 | Not classified | Z-0605-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Dec 20, 2006 | Not classified | Z-0606-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Dec 20, 2006 | Not classified | Z-0608-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
| Dec 20, 2006 | Not classified | Z-0604-2007 | Other | Guidewire restriction during use (excessive adhesive in the guidewire lumen) |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 5.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K982184 (Boston Scientific Scimed, Inc., 1998) has gone furthest, with 40 descendants of its own.
- 3 other devices also cite its predicate K911292.
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 intended for use in the treatment of biliary strictures produced by malignant neoplasms.
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/K964119 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964119: Wallstent Transhepatic Biliary Endoprosthesis.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964119
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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