# K073266: Wallflex Partially Covered Esophageal Stent System

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Feb 27, 2008 after 99 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: 3 generations back to K925406 (1995). 13 ancestors in all.
15 later devices descend from it; 4 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032930: Ultraflex Esophageal NG Stent System, Boston Scientific Corp (2003) Summary page 1.
- K012883: Ultraflex Esophageal Stent System, Ultraflex Diamondbiliary Stent System, Ultraflex Tracheobronchial Stent System, Boston Scientific Corp (2001) Summary page 1.
- K955347: Ultraflex, Boston Scientific Corp (1996) Summary page 1.
- K940838: Microvasive Ultraflex Esophageal Stent System, Boston Scientific Corp (1994) Summary page 1.
- K940395: Wallstent Esophageal Prosthesis, Boston Scientific Scimed, Inc. (1994) Summary page 1.
- K030559: Rusch Polyflex Stent for the Esophagus W/Introducer/Delivery System, Rusch Intl. (2003) Summary page 1.
- K010068: Rusch Polyflex Stent for the Esophagus with Introducer System, Rusch Intl. (2001) Summary page 1.
- K042065: Wallflex Enternal Colonic Stent and Anchor Lock Delivery System, Boston Scientific Corp (2004) Summary page 1.

## Most influential descendants
- K091510: Wallflex Esophageal Fully Covered Stent System, Models M00516700, M00516710, M00516720, M00516730 (2009), 14 descendants of its own
- 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

## Indications for use
The proposed device 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/K073266
Methodology: https://510kreport.com/methodology