# K955041: Instent Esophacoil Self-Expanding Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Instent, Inc.
- Decided: Feb 21, 1996 after 110 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K983297: Medtronic Instent Esophacoil Esophageal Stent System with Slow Release (1998), 0 descendants of its own
- K973584: Medtronic Instent Esophacoil Esophageal Stent System and Esophacoil Extension System (1998), 0 descendants of its own

Source page: https://510kreport.com/device/K955041
Methodology: https://510kreport.com/methodology