# K111611: Endomaxx Fully Covered Esophageal Stent

- Pathway: 510(k) (Special)
- Applicant: Merit Medical Systems, Inc.
- Decided: Jul 29, 2011 after 50 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: 4 generations back to K955347 (1996). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051621: Endoventions Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2005) Summary page 1.
- K080838: Alveolus Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2008) Summary page 1.

## Most influential descendants
- K251265: Resilience Fully Covered Esophageal Stent System (2025), 0 descendants of its own

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

Source page: https://510kreport.com/device/K111611
Methodology: https://510kreport.com/methodology