510(k) · Decided
DecidedWallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · FGE Stents, Drains And Dilators For The Biliary Ducts
Cleared on Dec 29, 2011 as substantially equivalent to K964119 (Boston Scientific Scimed, Inc., 1997) and 6 other predicates after a 119-day review. Its family tree reaches back 10 generations to 1992. 5 later devices descend from it.
- Decided
- Dec 29, 2011
- Review
- 119 days
- Class
- Class II
- Product code
- FGE
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 10 generations to K923119 (1992). 24 ancestors in all, the oldest K911292 (1991). 5 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 6 generations between
- 3 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 2 generations backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- 1 generation backK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- This deviceK112543 Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex…Boston Scientific Corporation · 2011
- Descendant · cites it directly · 4 of its ownK122072 Wallflextm Biliary RX Stent System (Uncovered, Partially Covered…Boston Scientific Corporation · 2012
- Descendant · 2 generations on · 3 of its ownK140630 Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · Recalled
- Descendant · 3 generations on · 1 of its ownK240464 WallFlex Biliary RX Stent System; Epic Biliary Stent System…Boston Scientific · 2024
- Descendant · 3 generations on · 1 of its ownK223469 WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation · 2023
- Descendant · 4 generations on · 0 of its ownK242950 WallFlex Biliary PLUS RX Stent SystemBoston Scientific · 2024
Show all 10 generations
- Root · 10 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 9 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 8 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 7 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 6 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 5 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 4 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 3 generations backK030107 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM…Boston Scientific Corp · 2003 · Recalled
- 2 generations backK061231 Wellflex Biliary RX Stent SystemBoston Scientific Corp · 2006
- 1 generation backK081733 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model…Boston Scientific Corp · 2008
- This deviceK112543 Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex…Boston Scientific Corporation · 2011
Most influential descendants
Showing 5 of 5 · See all- K122072Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)…Boston Scientific Corporation · 2012 · cites it directly4descendants
- K140630Wallflex Biliary RX Stent SystemBoston Scientific · 2014 · 2 generations on3descendants
- K240464WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully…Boston Scientific · 2024 · 3 generations on1descendant
- K223469WallFlex™ Biliary RX Stent SystemBoston Scientific Corporation · 2023 · 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 |
|---|---|---|---|---|---|
| −10 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −9 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −8 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −7 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −6 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −5 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −4 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −3 | K030107 | 100MM Wallstent RX Biliary Endoprosthesis, Models M00569800 8MM, M00569810 10MM | Boston Scientific Corp | 2003 | 1 |
| −2 | K061231 | Wellflex Biliary RX Stent System | Boston Scientific Corp | 2006 | — |
| −1 | K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890 | Boston Scientific Corp | 2008 | — |
| 0 (this device) | K112543 | Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary… | Boston Scientific Corporation | 2011 | — |
| +1 | K122072 | Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully… | Boston Scientific Corporation | 2012 | — |
| +2 | K140630 | Wallflex Biliary RX Stent System | Boston Scientific | 2014 | 1 |
| +3 | K240464 | WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary… | Boston Scientific | 2024 | — |
| +3 | K223469 | WallFlex™ Biliary RX Stent System | Boston Scientific Corporation | 2023 | — |
| +4 | K242950 | WallFlex Biliary PLUS RX Stent System | Boston Scientific | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 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? (7)
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…: FGE Classification: Class 11 3. Predicate Devices The Boston Scientific Corporation, Walistent Transhepatic Biliary Endoprosthesis (K9641 19), the Boston Scientific Corporation, Walistent Biliary Endoprosthesis (1(000308, K(993232) , and the Boston Scientific Co… | 1997 |
| * | K000308 | Wallstent Biliary EndoprosthesisSummary page 2…system dimensions, materials, and design features) as the predicate Walistent Transhepatic Biliary Stent System (K9641 19), the Walistent Biliary Endoprosthesis (K000308, K993232), and the WallFlex Biliary RX Stent System (K06 123 1, K(081733, K(083374, and K083627). The proposed device ha… | 2000 |
| * | K993232 | Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemSummary page 2…mensions, materials, and design features) as the predicate Walistent Transhepatic Biliary Stent System (K9641 19), the Walistent Biliary Endoprosthesis (K000308, K993232), and the WallFlex Biliary RX Stent System (K06 123 1, K(081733, K(083374, and K083627). The proposed device has the sam… | 1999 |
| * | K061231 | Wellflex Biliary RX Stent SystemSummary page 2…dicate Walistent Transhepatic Biliary Stent System (K9641 19), the Walistent Biliary Endoprosthesis (K000308, K993232), and the WallFlex Biliary RX Stent System (K06 123 1, K(081733, K(083374, and K083627). The proposed device has the same intended use and is placed using the same methodolog… | 2006 |
| * | K081733 | 10MM X 40MM Uncovered Wallflex Billiary RX Stent System, Model M00570890Summary page 1…n Scientific Corporation, Walistent Biliary Endoprosthesis (1(000308, K(993232) , and the Boston Scientific Corporation, WallFlex Biliary RX Stent System (K(06123 1, K081733, K083374, and K083627). 4. Device Description The WaIIFCXTM Biliary Transhepatic Stent System is comprised of two compo… | 2008 |
| * | K083374 | Wallflex Biliary RX Partially-Covered Stent SystemSummary page 1…fic Corporation, Walistent Biliary Endoprosthesis (1(000308, K(993232) , and the Boston Scientific Corporation, WallFlex Biliary RX Stent System (K(06123 1, K081733, K083374, and K083627). 4. Device Description The WaIIFCXTM Biliary Transhepatic Stent System is comprised of two components: th… | 2009 |
| * | K083627 | Wallflex Biliary RX Fully-Covered Stent System, Model M00570500,M00570510, M00570520…Summary page 1…Walistent Biliary Endoprosthesis (1(000308, K(993232) , and the Boston Scientific Corporation, WallFlex Biliary RX Stent System (K(06123 1, K081733, K083374, and K083627). 4. Device Description The WaIIFCXTM Biliary Transhepatic Stent System is comprised of two components: the implantable… | 2009 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K122072 | Wallflextm Biliary RX Stent System (Uncovered, Partially Covered, and Fully Covered)… | 2012 | 4 |
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 19 years and passes through 4 companies; a new generation was cleared every 2.2 years on median.
- 7 of the 24 ancestors have a recall of any class.
- Of its descendants, K122072 (Boston Scientific Corporation, 2012) has gone furthest, with 4 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. 2011, 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 WallFlex Biliary Transhepatic Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112543 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112543: Wallflex Biliary Transhepatic Uncovered Stent System, Wallflex Biliary Transhepatic Covered Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112543
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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