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WALLSTENT Esophageal Prosthesis

by Boston Scientific Scimed, Inc. 510(k)

Active United States

510(k) K940395

Overview

The WALLSTENT Esophageal Prosthesis is a self-expanding esophageal prosthesis designed to maintain patency in the esophagus. It features a unique stent design with a minimal free cell area and is constructed to provide structural support within the esophageal lumen. The device is intended for use as a prosthetic conduit to relieve obstruction caused by malignant or benign strictures.

The device is supplied in a sterile condition and is intended for single use. It is delivered via an intuitive delivery system that allows for reconstrainability during placement. The prosthesis is available in multiple sizes to accommodate different anatomical requirements. Storage should be kept in a dry environment at room temperature. The device is regulated under product code ESW and is classified as a Class II esophageal prosthesis.

AI-generated from registry data, 27 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK940395 Date20 Sep 1994ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
ESW
Device Class
Class II
Regulation
21 CFR Part 878.3610
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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