510(k) · Cleared
ClearedMedtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtech Instruments · ESW Prosthesis, Esophageal
Cleared on Jan 9, 1998 as substantially equivalent to K941487 (Instent, Inc., 1995) and 1 other predicate after a 109-day review. Its family tree reaches back 1 generation to 1995.
- Decided
- Jan 9, 1998
- Review
- 109 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.
- Root · 1 generation backK941487 Instent Esophacoil Esophageal ProsthesisInstent, Inc. · 1995
- This deviceK973584 Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil…Medtech Instruments · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K941487 | Instent Esophacoil Esophageal Prosthesis | Instent, Inc. | 1995 | — |
| 0 (this device) | K973584 | Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension… | Medtech Instruments | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
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 K261978 WallFlex Esophageal Stent System;Agile…score 15.3 · 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K941487 | Instent Esophacoil Esophageal Prosthesis Our OCR of the scanned summary read K944187, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Medtronic InStent EsophaCoil Esophageal Stent System”. | 1995 |
| * | K955041 | Instent Esophacoil Self-Expanding Stent SystemSummary page 1…ension Systems Name of Predicate Device These devices are considered substantially equivalent to the Medtronic InStent EsophaCoil Esophageal Stent System. (K944187 and K955041) Device Description The Medtronic InStent EsophaCoil Esophageal Stent is a self-expanding, tightly wound spiral Nitinol wire co… | 1996 |
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 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 | — |
What is it indicated for?
The Medtronic InStent EsophaCoil Esophageal Stent System is intended for use in the treatment of esophageal obstructions produced by malignant neoplasms.
The Medtronic InStent EsophaCoil Distal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the distal side of the stent.
The Medtronic InStent EsophaCoil Proximal Extension System is intended for use in extending previously implanted esophageal stents exhibiting tumor overgrowth on the proximal side of the stent.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973584 · printed Nov 5, 2026
Cite this page
510(k) Report. “K973584: Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973584
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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