# K973584: Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension System

- Pathway: 510(k) (Traditional)
- Applicant: Medtech Instruments
- Decided: Jan 9, 1998 after 109 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). 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”.
- K955041: Instent Esophacoil Self-Expanding Stent System, Instent, Inc. (1996) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K973584
Methodology: https://510kreport.com/methodology