510(k) · Cleared
Recalled · Class II · 2024Agile Esophageal 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 Apr 4, 2024 as substantially equivalent to K180144 (Boston Scientific Corporation, 2018) and 1 other predicate after a 122-day review. Its family tree reaches back 12 generations to 1992. 1 later device descends from it. It has been recalled 9 times.
- Decided
- Apr 4, 2024
- Review
- 122 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 9
- Predicates
- 2
Its longest line of descent runs back 12 generations to K923119 (1992). 47 ancestors in all, the oldest K911292 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 8 generations between
- 3 generations backK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- 2 generations backK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- 1 generation backK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- This deviceK233837 Agile Esophageal Stent SystemBoston Scientific Corporation · 2024
- Descendant · cites it directly · 0 of its ownK261978 WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire…Boston Scientific Corporation · 2026
Show all 12 generations
- Root · 12 generations backK923119 Wallstent Esophageal ProthesisSchneider U.S. Stent Div. · 1992
- 11 generations backK945494 Wallstent (R) Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1995 · Recalled
- 10 generations backK961296 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 9 generations backK964121 Wallstent Tracheobronchial EndoprosthesisBoston Scientific Scimed, Inc. · 1996 · Recalled
- 8 generations backK980163 Wallstent Tracheobronchial Endoprosthesis and Wallstent…Boston Scientific Scimed, Inc. · 1998 · Recalled
- 7 generations backK982184 Wallstent EndoprosthesisBoston Scientific Scimed, Inc. · 1998
- 6 generations backK012752 Wallstent RX Biliary Endoprostheses, Models 6961-6972 InclusiveBoston Scientific Corp · 2001 · Recalled
- 5 generations backK073667 Niti-S Biliary StentTaewoong Medical Co., Ltd. · 2008
- 4 generations backK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
- 3 generations backK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
- 2 generations backK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- 1 generation backK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
- This deviceK233837 Agile Esophageal Stent SystemBoston Scientific Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K923119 | Wallstent Esophageal Prothesis | Schneider U.S. Stent Div. | 1992 | — |
| −11 | K945494 | Wallstent (R) Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1995 | 1 |
| −10 | K961296 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −9 | K964121 | Wallstent Tracheobronchial Endoprosthesis | Boston Scientific Scimed, Inc. | 1996 | 1 |
| −8 | K980163 | Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial… | Boston Scientific Scimed, Inc. | 1998 | 1 |
| −7 | K982184 | Wallstent Endoprosthesis | Boston Scientific Scimed, Inc. | 1998 | — |
| −6 | K012752 | Wallstent RX Biliary Endoprostheses, Models 6961-6972 Inclusive | Boston Scientific Corp | 2001 | 1 |
| −5 | K073667 | Niti-S Biliary Stent | Taewoong Medical Co., Ltd. | 2008 | — |
| −4 | K113551 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2012 | 1 |
| −3 | K123205 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | 2013 | 1 |
| −2 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| −1 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
| 0 (this device) | K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | 2024 | — |
| +1 | 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 |
|---|---|---|
| 1991 | 2 | 0 |
| 1994 | 6 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 3 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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 K261978 WallFlex Esophageal Stent System;Agile…score 15.2 · 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 |
|---|---|---|---|
| * | K180144 | Agile Esophageal Stent System | 2018 |
| * | K211960 | Agile Esophageal OTW Stent SystemSummary page 6…osed Agile™ Esophageal Stent System are substantially equivalent to the previously cleared and currently marketed predicate Agile"" Esophageal Stent System (Kl 80144 and K211960). The proposed Agile Esophageal Stent System are identical to the predicate Agile Esophageal Stent System (Kl 80144 and K211960)… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2024 | Class II | Z-3291-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3288-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3294-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3287-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3295-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3293-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3289-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3290-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
| Aug 1, 2024 | Class II | Z-3292-2024 | Process control | WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment. |
The 5 latest of 9 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 32 years and passes through 5 companies; a new generation was cleared every 2.5 years on median.
- 15 of the 47 ancestors have a recall of any class.
- Of its descendants, K261978 (Boston Scientific Corporation, 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K180144.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 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/K233837 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233837: Agile Esophageal 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/K233837
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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