510(k) Report

510(k) · Cleared

Cleared

Esophageal Z-Stent with Dua Anti-Reflux Valve

K011591510(k) TraditionalCleared Jul 19, 2002421-day reviewClass II21 CFR 878.3610

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Wilson-Cook Medical, Inc. · ESW Prosthesis, Esophageal

Cleared on Jul 19, 2002 as substantially equivalent to K920218 (Wilson-Cook Medical, Inc., 1994) and 1 other predicate after a 421-day review. Its family tree reaches back 1 generation to 1994. 19 later devices descend from it.

Decided
Jul 19, 2002
Review
421 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K920218 (1994). 2 ancestors in all. 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 1 other ancestor2009: 1 descendant cleared2008: 1 descendant cleared2010: 2 descendants cleared2016: 1 descendant cleared2025: 1 descendant cleared2012: 1 descendant cleared2024: 3 descendants cleared2013: 1 descendant cleared2014: 1 descendant cleared2022: 1 descendant cleared2021: 2 descendants cleared2020: 2 descendants cleared2018: 1 descendant cleared2026: 1 descendant clearedK920218 · Esophageal Z-Stent · Wilson-Cook Medical, Inc. · 1994 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 2 descendants2 generations forward: 7 descendants3 generations forward: 5 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K920218 · Esophageal Z-Stent · Wilson-Cook Medical, Inc. · 1994 · recalled0+5
  1. Root · 1 generation backK920218 Esophageal Z-StentWilson-Cook Medical, Inc. · 1994 · Recalled
  2. This deviceK011591 Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc. · 2002
  3. Descendant · cites it directly · 15 of its ownK080782 Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · Recalled
  4. Descendant · 2 generations on · 10 of its ownK113551 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · Recalled
  5. Descendant · 2 generations on · 9 of its ownK123205 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · Recalled
  6. Descendant · 3 generations on · 3 of its ownK211706 Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021
  7. Descendant · 3 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 22012: 12013: 12014: 12016: 12018: 12020: 22021: 22022: 12024: 32025: 12026: 1
2008high 3 (2024) · low 0 (2011)2026

Most influential descendants

Showing 5 of 19 · See all
  • K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd. · 2009 · cites it directly15descendants
  • K113551Esophageal TTS StentTaewoong Medical Co., Ltd. · 2012 · 2 generations on10descendants
  • K123205Esophageal TTS StentTaewoong Medical Co., Ltd. · 2013 · 2 generations on9descendants
  • K211706Esophageal TTS StentTaewoong Medical Co., Ltd. · 2021 · 3 generations on3descendants
  • K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K920218Esophageal Z-StentWilson-Cook Medical, Inc.19941
0 (this device)K011591Esophageal Z-Stent with Dua Anti-Reflux ValveWilson-Cook Medical, Inc.2002—
+1K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.20091
+2K113551Esophageal TTS StentTaewoong Medical Co., Ltd.20121
+2K123205Esophageal TTS StentTaewoong Medical Co., Ltd.20131
+3K211706Esophageal TTS StentTaewoong Medical Co., Ltd.2021—
+3K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201020
201210
201310
201410
201610
201810
202020
202120
202210
202430
202510
202610
FIG. 1 — Lineage of K011591, 1994–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261978 WallFlex Esophageal Stent System;Agile…score 15.3 · 13 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K920218Esophageal Z-Stent
Summary page 1
…I Document Control 1 1 Number Covered fsophageal Z- I Wilson-Cook Medical Inc. 1 K920218 Stent Wilson-Cook Colonic Z- Wilson-Cook Met Stent Page 1 of 2 === P…
Wilson-Cook Medical, Inc.19941
*K990034Wilson-Cook Colonic Z-Stent
Summary page 2
…with Dua Anti-Reflux Coated Esophageal Z- Cook Colonic Z- ValveCSubject of Stent (K920218) S t e n t (K990034) "Special" 5lO(k)j Mended Use Used to maintain Used to maintain patency Used to m…
Med Institute, Inc.2000—

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K080782Niti-S Esophageal StentTaewoong Medical Co., Ltd.200915
K080359Evolution Esophageal Stent SystemCook Ireland, Ltd.20082

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?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K080782 (Taewoong Medical Co., Ltd., 2009) has gone furthest, with 15 descendants of its own.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ESW

3in 2025

2008: 52009: 32010: 32011: 12012: 22013: 22016: 12018: 22019: 12020: 12021: 42022: 12024: 42025: 32026 (partial year): 1
2007high 5 (2008) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ESW

90in 2025

2008: 99 days median2009: 35 days median2010: 206 days median2021: 139 days median2024: 130 days median2025: 90 days median
2007high 206 (2010) · low 35 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ESW

25in 2010

2010: 25
2007high 25 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ESW

120in 2025

2007: 882008: 1532009: 2392010: 2552011: 1402012: 1212013: 1452014: 1692015: 1752016: 1532017: 872018: 862019: 1672020: 1552021: 772022: 1092023: 1552024: 1662025: 120
2007high 255 (2010) · low 77 (2021)2025

MAUDE reports naming product code ESW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—088
20085990153
20093350239
2010320625255
20111—0140
20122—0121
20132—0145
20140—0169
20150—0175
20161—0153
20170—087
20182—086
20191—0167
20201—0155
20214139077
20221—0109
20230—0155
202441300166
20253900120
20261—0—

What is it indicated for?

Used to maintain patency of malignant esophageal strictures and/or to seal tracheoesophageal fistulas.

Indications for use as stated in the FDA summary.

More from Wilson-Cook Medical, Inc.

125 FDA decisions under this applicant name. See the company

  • K253302Hemospray Endoscopic Hemostat (HEMO-[X])Wilson-Cook Medical, Inc. · 20261 recall
  • K243568Teslatome Bipolar Sphincterotome; Tesla BiCord Active CordWilson-Cook Medical, Inc. · 20251 recall
  • K213356Entuit PEG, Entuit PEGJWilson-Cook Medical, Inc. · 2022
  • K212323Instinct Plus Endoscopic Clipping DeviceWilson-Cook Medical, Inc. · 20211 recall
  • K201322Entuit Nasal Jejunal Feeding TubeWilson-Cook Medical, Inc. · 2020

Recent decisions in ESW

The ESW category page

  • K261978WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemBoston Scientific Corporation · 2026
  • K243619Niti-S Esophageal Stent; Esophageal TTS StentTaewoong Medical Co., Ltd. · 2025
  • K253327HANAROSTENT Esophagus Upper (CCC)M.I.Tech Co., Ltd. · 2025
  • K251265Resilience Fully Covered Esophageal Stent SystemMerit Medical Systems, Inc. · 2025
  • K233939Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent SystemBoston Scientific · 202422 recalls

https://510kreport.com/device/K011591 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011591: Esophageal Z-Stent with Dua Anti-Reflux Valve.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011591

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026