510(k) · Cleared
ClearedWallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · ESW Prosthesis, Esophageal
Cleared on Jul 10, 2026 as substantially equivalent to K233939 (Boston Scientific, 2024) and 1 other predicate after a 28-day review. Its family tree reaches back 13 generations to 1992.
- Decided
- Jul 10, 2026
- Review
- 28 days
- Class
- Class II
- Product code
- ESW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K923119 (1992). 65 ancestors in all, the oldest K894380 (1989). No later device cites it as a predicate yet.
- Root · 13 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 9 generations between
- 3 generations backK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- 2 generations backK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- 1 generation backK233837 Agile Esophageal Stent SystemBoston Scientific Corporation · 2024 · Recalled
- This deviceK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
Show all 13 generations
- Root · 13 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 12 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 11 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 10 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 9 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 8 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 7 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 6 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 5 generations backK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- 4 generations backK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- 3 generations backK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- 2 generations backK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- 1 generation backK233837 Agile Esophageal Stent SystemBoston Scientific Corporation · 2024 · Recalled
- This deviceK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −12 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −11 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −10 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −9 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −8 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −7 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −6 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| −5 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| −4 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| −3 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| −2 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
| −1 | K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024 | 9 |
| 0 (this device) | K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent… | Boston Scientific Corporation | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 6 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2024 | 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 ESW? 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 ESW device
- #1 K243619 Niti-S Esophageal Stent; Esophageal TTS Stentscore 13.9 · 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? (2)
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 |
|---|---|---|---|
| * | K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemSummary page 5…hageal Stent System Common Name Esophageal Prosthesis Classification Name Prosthesis, Esophageal Clearance Number K233939 Regulation Number 21 CFR 878.3610 Product Code ESW Classification Clas… | 2024 |
| * | K233837 | Agile Esophageal Stent SystemSummary page 6…978 Page 2 of 4 Common Name Esophageal Prosthesis Classification Name Prosthesis, Esophageal Clearance Number K233837 Regulation Number 21 CFR 878.3610 Product Code ESW Classification Clas… | 2024 |
What descends from it?
No later submission names this one as a predicate yet.
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 34 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 18 of the 65 ancestors have a recall of any class.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · ESW
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ESW
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ESW
25in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ESW
120in 2025
MAUDE reports naming product code ESW, 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 | 88 |
| 2008 | 5 | 99 | 0 | 153 |
| 2009 | 3 | 35 | 0 | 239 |
| 2010 | 3 | 206 | 25 | 255 |
| 2011 | 1 | — | 0 | 140 |
| 2012 | 2 | — | 0 | 121 |
| 2013 | 2 | — | 0 | 145 |
| 2014 | 0 | — | 0 | 169 |
| 2015 | 0 | — | 0 | 175 |
| 2016 | 1 | — | 0 | 153 |
| 2017 | 0 | — | 0 | 87 |
| 2018 | 2 | — | 0 | 86 |
| 2019 | 1 | — | 0 | 167 |
| 2020 | 1 | — | 0 | 155 |
| 2021 | 4 | 139 | 0 | 77 |
| 2022 | 1 | — | 0 | 109 |
| 2023 | 0 | — | 0 | 155 |
| 2024 | 4 | 130 | 0 | 166 |
| 2025 | 3 | 90 | 0 | 120 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The WallFlex Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261978 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) 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/K261978
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026