510(k) · Cleared
Recalled · 2003Rusch Polyflex Stent for the Esophagus with Introducer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rusch Intl. · ESW Prosthesis, Esophageal
Cleared on Feb 8, 2001 after a 31-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 16 later devices descend from it. It has been recalled 9 times.
- Decided
- Feb 8, 2001
- Review
- 31 days
- Class
- Class II
- Product code
- ESW
- Recalls
- 9
- Predicates
- 0
16 later devices descend from it, 1 citing it directly.
- This deviceK010068 Rusch Polyflex Stent for the Esophagus with Introducer SystemRusch Intl. · 2001
- Descendant · cites it directly · 15 of its ownK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
- Descendant · 2 generations on · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
- Descendant · 2 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
- Descendant · 3 generations on · 3 of its ownK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
Showing 5 of 16 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 16 · See all- K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008 · cites it directly15descendants
- K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · 2 generations on14descendants
- K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · 2 generations on3descendants
- K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018 · 3 generations on3descendants
- K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K010068 | Rusch Polyflex Stent for the Esophagus with Introducer System | Rusch Intl. | 2001 | — |
| +1 | K073266 | Wallflex Partially Covered Esophageal Stent System | Boston Scientific Corp | 2008 | — |
| +2 | K091510 | Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710… | Boston Scientific Corporation | 2009 | — |
| +2 | K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | 2018 | — |
| +3 | K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | 2018 | — |
| +2 | K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (16)
See all 161 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073266 | Wallflex Partially Covered Esophageal Stent System | 2008 | 15 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 16, 2003 | Not classified | Z-0818-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0820-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0824-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0819-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0821-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0822-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0823-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0825-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
| Apr 16, 2003 | Not classified | Z-0826-03 | Other | Radiopaque marker bands may not be visible under fluoroscopy |
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?
- Of its descendants, K073266 (Boston Scientific Corp, 2008) has gone furthest, with 15 descendants of its own.
How does its category compare?
All ESW devicesESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K010068 · printed Nov 6, 2026
Cite this page
510(k) Report. “K010068: Rusch Polyflex Stent for the Esophagus with Introducer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010068
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026