# K080838: Alveolus Alimaxx-E Esophageal Stent System

- Pathway: 510(k) (Special)
- Applicant: Alveolus, Inc.
- Decided: Apr 24, 2008 after 30 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: 3 generations back to K955347 (1996). 4 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 22 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.

## Most influential descendants
- 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
- K201160: HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) (2021), 2 descendants of its own

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

Source page: https://510kreport.com/device/K080838
Methodology: https://510kreport.com/methodology