# K211960: Agile Esophageal OTW Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Nov 22, 2021 after 151 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: 11 generations back to K923119 (1992). 46 ancestors in all.
2 later devices descend from it; 1 cites 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)
- K180144: Agile Esophageal Stent System, Boston Scientific Corporation (2018) Summary page 5.
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730, Boston Scientific Corporation (2009) Summary page 5.
- K073266: Wallflex Partially Covered Esophageal Stent System, Boston Scientific Corp (2008) Summary page 5.

## Most influential descendants
- 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 Partially Covered and Fully Covered OTW 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/K211960
Methodology: https://510kreport.com/methodology