# K051621: Endoventions Alimaxx-E Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Alveolus, Inc.
- Decided: Jul 11, 2005 after 21 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: 2 generations back to K955347 (1996). 3 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 1.
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System, Rusch Intl. (2003) Summary page 1.

## Most influential descendants
- K080838: Alveolus Alimaxx-E Esophageal Stent System (2008), 17 descendants of its own
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- K180144: Agile Esophageal Stent System (2018), 3 descendants of its own
- K172813: Esophageal Stent System (2018), 3 descendants of its own
- K211960: Agile Esophageal OTW Stent System (2021), 2 descendants of its own

## Indications for use
The Endoventions ALIMAXX-E Esophageal Stent System is intended for maintaining esophageal lumen patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors. The stent is also indicated for occlusion of esophageal fistulae.

Source page: https://510kreport.com/device/K051621
Methodology: https://510kreport.com/methodology