510(k) Report

510(k) · Cleared

Cleared

Medtronic Instent Esophacoil Esophageal Stent System with Slow Release

K983297510(k) TraditionalCleared Dec 18, 199888-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

Medtronic Instent, Inc. · ESW Prosthesis, Esophageal

Cleared on Dec 18, 1998 as substantially equivalent to K941487 (Instent, Inc., 1995) and 1 other predicate after an 88-day review. Its family tree reaches back 1 generation to 1995.

Decided
Dec 18, 1998
Review
88 days
Class
Class II
Product code
ESW
Recalls
None
Predicates
2

Its longest line of descent runs back 1 generation to K941487 (1995). 2 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1996: 1 other ancestorK941487 · Instent Esophacoil Esophageal Prosthesis · Instent, Inc. · 1995199619982000
Other ancestors, by generation 1 generation back: 1 other ancestor K941487 · Instent Esophacoil Esophageal Prosthesis · Instent, Inc. · 19950
  1. Root · 1 generation backK941487 Instent Esophacoil Esophageal ProsthesisInstent, Inc. · 1995
  2. This deviceK983297 Medtronic Instent Esophacoil Esophageal Stent System with Slow ReleaseMedtronic Instent, Inc. · 1998
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K941487Instent Esophacoil Esophageal ProsthesisInstent, Inc.1995—
0 (this device)K983297Medtronic Instent Esophacoil Esophageal Stent System with Slow ReleaseMedtronic Instent, Inc.1998—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199610
FIG. 1 — Lineage of K983297, 1995–1998Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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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? (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
*K941487Instent Esophacoil Esophageal Prosthesis
Summary page 1
…Endoprosthesis Proprietary Name EsophaCoil Esophageal Stent System with Slow Release B. Name of Predicate Device EsophaCoil Esophageal Stent System and Variable Release K941487 and K955041 respectively C. Device Description The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is se…
Instent, Inc.1995—
*K955041Instent Esophacoil Self-Expanding Stent System
Summary page 1
…is Proprietary Name EsophaCoil Esophageal Stent System with Slow Release B. Name of Predicate Device EsophaCoil Esophageal Stent System and Variable Release K941487 and K955041 respectively C. Device Description The Medtronic InStent EsophaCoil Esophageal Stent System with Slow Release is self-expandabl…
Instent, Inc.1996—

Also cleared against K941487: 1 other device →

What descends from it?

No later submission names this one as a predicate yet.

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?

  • None of the 2 ancestors has a recall.
  • 1 other device also cites its predicate K941487.

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?

The EsophaCoil Slow Release esophageal prosthesis is indicated for use in the treatment of esophageal obstructions produced by malignant neoplasms.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K941487

1 other device cites the same predicate.

  • K973584Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension SystemMedtech Instruments · 1998

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/K983297 · printed Nov 5, 2026

Cite this page

510(k) Report. “K983297: Medtronic Instent Esophacoil Esophageal Stent System with Slow Release.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K983297

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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