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Wallstent Enteral Endoprothesis

by Boston Scientific Scimed, Inc. 510(k)

Active United States

510(k) K954290

Overview

The Wallstent Enteral Endoprosthesis is a metallic, expandable stent designed for placement within the enteral tract. It is classified as a colonic stent and is intended to maintain lumen patency by providing structural support to strictures caused by malignant neoplasms, improving gastrointestinal flow in palliative settings.

This device is supplied as a single-use, sterile endoprosthesis and is intended for physician placement under radiographic guidance. It is classified under FDA device class II (MQR product code) and has received 510(k) clearance. The Wallstent Enteral Endoprosthesis is available in multiple sizes and configurations, as referenced by its FEI numbers, and is regulated under 21 CFR 878.3610. Storage and handling must comply with sterile medical device protocols.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK954290 Date10 Jul 1996ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • 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
MQR
Device Class
Class II
Regulation
21 CFR Part 878.3610
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is the Wallstent Enteral Endoprosthesis used for?

    The Wallstent Enteral Endoprosthesis is designed to maintain lumen patency in the enteral tract by providing structural support to strictures caused by malignant neoplasms. It is specifically intended for palliative use to improve gastrointestinal flow in patients with blockages due to tumors.

  • How is the Wallstent Enteral Endoprosthesis supplied and prepared for use?

    The Wallstent Enteral Endoprosthesis is supplied as a single-use, sterile device. It must be handled according to standard sterile medical device protocols to ensure proper sterility before physician placement under radiographic guidance.

  • Is the Wallstent Enteral Endoprosthesis reusable or intended for single-use?

    This device is explicitly intended for single-use only. After deployment, it should not be reused, as reuse could compromise sterility and patient safety.

  • What sizes and configurations are available for the Wallstent Enteral Endoprosthesis?

    The Wallstent Enteral Endoprosthesis comes in multiple sizes and configurations, each identified by a unique FEI number. These include: 3002807036, 3002807314, 3009526575, 3003902943, 1000121056, 3040096051, 3010273872, 3005099803, 3008146331, 3011458193, 3005580113, and 3001845648. These variations allow clinicians to select the appropriate size for their patient’s anatomical needs.

  • What regulatory pathway does the Wallstent Enteral Endoprosthesis follow?

    The Wallstent Enteral Endoprosthesis is classified under FDA device class II with the product code MQR and is regulated under 21 CFR 878.3610. It has received 510(k) clearance, meaning it is considered substantially equivalent to a legally marketed device already on the market.