# K251265: Resilience Fully Covered Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 23, 2025 after 90 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: 5 generations back to K955347 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111611: Endomaxx Fully Covered Esophageal Stent, Merit Medical Systems, Inc. (2011) Summary page 5.

## Indications for use
The Resilience Fully Covered Esophageal Stent System is intended for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of esophageal fistulae.

Source page: https://510kreport.com/device/K251265
Methodology: https://510kreport.com/methodology