# K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730

- Pathway: 510(k) (Special)
- Applicant: Boston Scientific Corporation
- Decided: Jun 26, 2009 after 35 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: 4 generations back to K925406 (1995). 16 ancestors in all.
14 later devices descend from it; 6 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073266: Wallflex Partially Covered Esophageal Stent System, Boston Scientific Corp (2008) Summary page 1.
- K051621: Endoventions Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2005) Summary page 1.
- K080838: Alveolus Alimaxx-E Esophageal Stent System, Alveolus, Inc. (2008) Summary page 1.

## Most influential descendants
- 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
- K092144: Bonastent Esophageal, Models BE and Ber, Bonastent Esophageal U.E.S. Flange and Flare, Models Befg and Befr (2010), 2 descendants of its own

## Indications for use
The WallFlex Esophageal Fully Covered 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 fistula.

Source page: https://510kreport.com/device/K091510
Methodology: https://510kreport.com/methodology