510(k) Report

510(k) · Cleared

Cleared

Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System

K030559510(k) TraditionalCleared Jun 30, 2003129-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

Rusch Intl. · ESW Prosthesis, Esophageal

Cleared on Jun 30, 2003 after a 129-day review. The FDA summary names its predicate without a number. 22 later devices descend from it.

Decided
Jun 30, 2003
Review
129 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
0

22 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 2008: 3 descendants cleared2006: 1 descendant cleared2005: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared2010: 1 descendant cleared2018: 2 descendants cleared2021: 3 descendants cleared2024: 2 descendants cleared2014: 2 descendants cleared2025: 2 descendants cleared2020: 1 descendant cleared2023: 1 descendant cleared2026: 1 descendant clearedReference device: K982614 · Rusch Polyflex Stent Kit · Rusch Intl. · 1998200020052010201520202025
  1. This deviceK030559 Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl. · 2003
  2. Descendant · cites it directly · 19 of its ownK051621 Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005
  3. Descendant · 2 generations on · 17 of its ownK080838 Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008
  4. Descendant · cites it directly · 15 of its ownK073266 Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp · 2008
  5. Descendant · 2 generations on · 14 of its ownK091510 Wallflex Esophageal Fully Covered Stent System, Models M00516700…Boston Scientific Corporation · 2009
  6. Descendant · 2 generations on · 3 of its ownK180144 Agile Esophageal Stent SystemBoston Scientific Corporation · 2018

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 32009: 12010: 12011: 12014: 22018: 22020: 12021: 32023: 12024: 22025: 22026: 1
2005high 3 (2008) · low 0 (2007)2026

Most influential descendants

Showing 5 of 22 · See all
  • K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2005 · cites it directly19descendants
  • K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc. · 2008 · 2 generations on17descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K030559Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery SystemRusch Intl.2003—
+1K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc.2005—
+2K080838Alveolus Alimaxx-E Esophageal Stent SystemAlveolus, Inc.2008—
+1K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp2008—
+2K091510Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710…Boston Scientific Corporation2009—
+2K180144Agile Esophageal Stent SystemBoston Scientific Corporation2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200830
200910
201010
201110
201420
201820
202010
202130
202310
202420
202520
202610
FIG. 1 — Lineage of K030559, 2003–2026Source: 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 15.2 · 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? (5)

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
*—Hood Esophageal Prosthesis
Named without a submission number
—
*—Boston Scientific Ultraflex
Named without a submission number
—
*—Boston Scientific Wall Stent
Named without a submission number
—
*—Cook, Inc. Esophageal Z-Stent
Named without a submission number
—
*—Wilson-Cook Esophageal Prosthesis Set
Named without a submission number
—
†K982614Rusch Polyflex Stent KitRusch Intl.1998—

What descends from it? (22)

See all 22

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

NumberDeviceApplicantDecidedDescendants
K051621Endoventions Alimaxx-E Esophageal Stent SystemAlveolus, Inc.200519
K073266Wallflex Partially Covered Esophageal Stent SystemBoston Scientific Corp200815
K080332Polyflex Stent System with Delivery System, Model M00514270, M00514280, 00514290…Boston Scientific Corporation20080
K060239Aleolus/Enoventions,Alimaxx-E DV Esophageal Stent SystemAlveolus, Inc.20060

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?

  • Of its descendants, K051621 (Alveolus, Inc., 2005) has gone furthest, with 19 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?

Stenting :

Esophageal stenoses (strictures), such as stenting refractory benign strictures and/or malignant strictures

Esophageal-respiratory-fistula

Maintaining esophagus lumen patency in esophageal strictures caused by intrinsic or extrinsic tumors

Indications for use as stated in the FDA summary.

More from Rusch Intl.

43 FDA decisions under this applicant name. See the company

  • K033023Intermittent Urethral CathetersRusch Intl. · 2003
  • K023666Rusch Guided Cholangiography CatheterRusch Intl. · 2003
  • K023918Rusch Crystal Clear Tracheostomy Sets, Cuffed and CufflessRusch Intl. · 20032 recalls
  • K023964Rusch Microlaryngeal TubeRusch Intl. · 2002
  • K021540Rusch Edgar TubeRusch Intl. · 2002

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/K030559 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030559

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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