# K233837: Agile Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corporation
- Decided: Apr 4, 2024 after 122 days
- Product code: ESW (Prosthesis, Esophageal)
- Device class: 2
- Regulation: 21 CFR 878.3610
- Recalls of this device: 9 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K923119 (1992). 47 ancestors in all.
1 later device descends 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)
- K211960: Agile Esophageal OTW Stent System, Boston Scientific Corporation (2021) Summary page 6.

## Most influential descendants
- K261978: WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System (2026), 0 descendants of its own

## Recalls of this device
- Aug 1, 2024 · Class II · Z-3291-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3288-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3294-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3287-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3295-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3293-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3289-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3290-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.
- Aug 1, 2024 · Class II · Z-3292-2024: WallFlexTM Esophageal Stent System and AgileTM Esophageal Over the Wire (OTW) Stent System due to the potential for delivery catheter tip detachment.

## 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/K233837
Methodology: https://510kreport.com/methodology