# K180144: Agile Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Sep 21, 2018 after 246 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: 10 generations back to K923119 (1992). 45 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 49 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730, Boston Scientific Corporation (2009) Summary page 4.
- K073266: Wallflex Partially Covered Esophageal Stent System, Boston Scientific Corp (2008) Summary page 4.
- K123205: Esophageal TTS Stent, Taewoong Medical Co., Ltd. (2013) Summary page 4.
- K080838: Alveolus Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2008) Summary page 4.

## Most influential descendants
- K211960: Agile Esophageal OTW Stent System (2021), 2 descendants of its own
- K233837: Agile Esophageal Stent System (2024), 1 descendant of its own
- K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (2026), 0 descendants of its own

## Indications for use
The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Source page: https://510kreport.com/device/K180144
Methodology: https://510kreport.com/methodology