510(k) Report

510(k) · Cleared

Cleared

Wallflex Partially Covered Esophageal Stent System

K073266510(k) TraditionalCleared Feb 27, 200899-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

Boston Scientific Corp · ESW Prosthesis, Esophageal

Cleared on Feb 27, 2008 as substantially equivalent to K032930 (Boston Scientific Corp, 2003) and 7 other predicates after a 99-day review. Its family tree reaches back 3 generations to 1995. 15 later devices descend from it.

Decided
Feb 27, 2008
Review
99 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
8

Its longest line of descent runs back 3 generations to K925406 (1995). 13 ancestors in all, the oldest K940838 (1994). 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2004: 1 other ancestor2003: 3 other ancestors2001: 1 other ancestor1996: 2 other ancestors1994: 2 other ancestors2000: 1 other ancestor2010: 1 descendant cleared2018: 2 descendants cleared2009: 1 descendant cleared2021: 3 descendants cleared2024: 2 descendants cleared2014: 2 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant cleared2025: 1 descendant clearedK925406 · Biliary Endoprostheses W/Unistep Delivery System · Schneider Intl., Ltd. · 1995K962899 · Ultraflex Diamond · Boston Scientific Corp · 1997K012883 · Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System · Boston Scientific Corp · 2001 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 7 other ancestors2 generations back: 3 other ancestors 1 generation forward: 4 descendants2 generations forward: 5 descendants3 generations forward: 4 descendants4 generations forward: 2 descendants K012883 · Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System · Boston Scientific Corp · 2001 · recalledK962899 · Ultraflex Diamond · Boston Scientific Corp · 1997K925406 · Biliary Endoprostheses W/Unistep Delivery System · Schneider Intl., Ltd. · 19950
  1. Root · 3 generations backK925406 Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd. · 1995
  2. 2 generations backK962899 Ultraflex DiamondBoston Scientific Corp · 1997
  3. 1 generation backK012883 Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent…Boston Scientific Corp · 2001 · Recalled
  4. This deviceK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
  5. Descendant · cites it directly · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
  6. Descendant · cites it directly · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018
  7. Descendant · 2 generations on · 3 of its ownK172813 Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018
  8. Descendant · cites it directly · 2 of its ownK211960 Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021
  9. Descendant · 3 generations on · 2 of its ownK201160 HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2009: 12010: 12014: 22018: 22020: 12021: 32023: 12024: 22025: 12026: 1
2009high 3 (2021) · low 0 (2011)2026

Most influential descendants

Showing 5 of 15 · See all
  • K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation · 2009 · cites it directly14descendants
  • K180144Agile Esophageal Stent SystemBoston Scientific Corporation · 2018 · cites it directly3descendants
  • K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd. · 2018 · 2 generations on3descendants
  • K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation · 2021 · cites it directly2descendants
  • K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd. · 2021 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−3K925406Biliary Endoprostheses W/Unistep Delivery SystemSchneider Intl., Ltd.1995—
−2K962899Ultraflex DiamondBoston Scientific Corp1997—
−1K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System…Boston Scientific Corp200146
0 (this device)K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp2008—
+1K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710…Boston Scientific Corporation2009—
+1K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018—
+2K172813Esophageal Stent SystemMicro-Tech (Nanjing) Co., Ltd.2018—
+1K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation2021—
+3K201160HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN)M.I.Tech Co., Ltd.2021—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199420
199620
200010
200110
200330
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201010
201420
201820
202010
202130
202310
202420
202510
202610
FIG. 1 — Lineage of K073266, 1995–2026Source: 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? (8)

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
*K032930Ultraflex Esophageal NG Stent System
Summary page 1
…Product Code: ESW Classification: Class II per 21 CFR 878.3610 3. Predicate Devices: Stent: UltraflexTM Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent Sy…
Boston Scientific Corp200316
*K012883Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex…
Summary page 1
…uct Code: ESW Classification: Class II per 21 CFR 878.3610 3. Predicate Devices: Stent: UltraflexTM Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K03…
Boston Scientific Corp200146
*K955347Ultraflex
Summary page 1
…ESW Classification: Class II per 21 CFR 878.3610 3. Predicate Devices: Stent: UltraflexTM Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K030559 and…
Boston Scientific Corp1996—
*K940838Microvasive Ultraflex Esophageal Stent System
Summary page 1
…ation: Class II per 21 CFR 878.3610 3. Predicate Devices: Stent: UltraflexTM Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K030559 and K010068) Del…
Boston Scientific Corp1994—
*K940395Wallstent Esophageal Prosthesis
Summary page 1
…evices: Stent: UltraflexTM Covered Esophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K030559 and K010068) Delivery System: Wallflex ~m Enteral Colonic S…
Boston Scientific Scimed, Inc.1994—
*K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System
Summary page 1
…sophageal NG Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K030559 and K010068) Delivery System: Wallflex ~m Enteral Colonic Stent System and Anchor Lock Delivery System (K042065)…
Rusch Intl.2003—
*K010068Rusch Polyflex Stent for the Esophagus with Introducer System
Summary page 1
…Stent System (K032930, K012883, K955347, and K940838) Wallstent TM Esophageal II Stent (K940395) PolyflexTM Esophageal Stent System (K030559 and K010068) Delivery System: Wallflex ~m Enteral Colonic Stent System and Anchor Lock Delivery System (K042065) 4. Device…
Rusch Intl.20019
*K042065Wallflex Enternal Colonic Stent and Anchor Lock Delivery System
Summary page 1
…PolyflexTM Esophageal Stent System (K030559 and K010068) Delivery System: Wallflex ~m Enteral Colonic Stent System and Anchor Lock Delivery System (K042065) 4. Device Description: The proposed WaIlFlexTM Partially Covered Esophageal Stent System consists of a self-…
Boston Scientific Corp20041

Also cleared against K032930: 6 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720…Boston Scientific Corporation200914
K180144Agile Esophageal Stent SystemBoston Scientific Corporation20183
K211960Agile Esophageal OTW Stent SystemBoston Scientific Corporation20212
K092144Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare…Endochoice, Inc.20102

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 13 years and passes through 2 companies; a new generation was cleared every 4.4 years on median.
  • 4 of the 13 ancestors have a recall of any class.
  • Of its descendants, K091510 (Boston Scientific Corporation, 2009) has gone furthest, with 14 descendants of its own.
  • 6 other devices also cite its predicate K032930.

How does its category compare?

All ESW devices

ESW Prosthesis, Esophageal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

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?

The proposed device is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula

Indications for use as stated in the FDA summary.

Also cleared against K032930

6 other devices cite the same predicate.

  • K093537Hanarostent Esophagus (CCC)M.I.Tech Co., Ltd. · 2010
  • K091816Ultraflex Esophageal NG Stent SystemBoston Scientific Corporation · 20099 recalls
  • K080359Evolution Esophageal Stent SystemCook Ireland, Ltd. · 2008
  • K043260Orthocon LLC Orthostat Hemostatic Bone PuttyOrthocon, LLC · 2005
  • K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
  • K041648Niti-S Stent & Introducer, Model EoxxxxTaewoong Medical Co., Ltd. · 2005

More from Boston Scientific Corp

4,014 FDA decisions under this applicant name. See the company

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  • P900056/S226ROTAPRO™ Rotational Atherectomy SystemsBoston Scientific Corp · 2026
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  • P150031/S100Vercise DBS SystemsBoston Scientific Corp · 2026
  • N970003/S311ALTRUA™ 2 (Model S722); ESSENTIO™ (Model L121); PROPONENT™ (Model L221); ACCOLADE™ (Model L321); ALTRUA™ 2…Boston Scientific Corp · 2026

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/K073266 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073266: Wallflex Partially Covered Esophageal Stent System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073266

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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