# K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jul 10, 2026 after 28 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: 13 generations back to K923119 (1992). 65 ancestors in all.
No later device cites it as a predicate yet.
0 of 66 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233939: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System, Boston Scientific (2024) Summary page 5.
- K233837: Agile Esophageal Stent System, Boston Scientific Corporation (2024) Summary page 6.

## Indications for use
The WallFlex 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. 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/K261978
Methodology: https://510kreport.com/methodology