# K983297: Medtronic Instent Esophacoil Esophageal Stent System with Slow Release

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Instent, Inc.
- Decided: Dec 18, 1998 after 88 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941487 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941487: Instent Esophacoil Esophageal Prosthesis, Instent, Inc. (1995) Summary page 1.
- K955041: Instent Esophacoil Self-Expanding Stent System, Instent, Inc. (1996) Summary page 1.

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

Source page: https://510kreport.com/device/K983297
Methodology: https://510kreport.com/methodology