Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart D — Prosthetic Devices](/submissions/SU/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610) → MUM — Stent, Metallic, Expandable, Duodenal

# MUM · Stent, Metallic, Expandable, Duodenal

_General, Plastic Surgery · 21 CFR 878.3610 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM

## Overview

- **Product Code:** MUM
- **Device Name:** Stent, Metallic, Expandable, Duodenal
- **Regulation:** [21 CFR 878.3610](/submissions/SU/subpart-d%E2%80%94prosthetic-devices/878.3610)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **Implant:** yes

## Identification

An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.

## Classification Rationale

Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

## Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

## Recent Cleared Devices (6 of 6)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K250663](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K250663.md) | Niti-S Duodenal Comfort Stent, Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | Mar 31, 2025 | SESE |
| [K223067](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K223067.md) | Niti-S Duodenal Stent; Niti-S Colonic Comfort Stent | Taewoong Medical Co., Ltd. | Jun 14, 2023 | SESE |
| [K163468](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K163468.md) | Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered | Cook Ireland, Ltd. | May 4, 2017 | SESE |
| [K101530](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K101530.md) | EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D | Cook Ireland, Ltd. | Mar 29, 2011 | SESE |
| [K062750](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K062750.md) | WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 | Boston Scientific Corp | Dec 4, 2006 | SESE |
| [K980113](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM/K980113.md) | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | Apr 3, 1998 | SESE |

## Top Applicants

- Cook Ireland, Ltd. — 2 clearances
- Taewoong Medical Co., Ltd. — 2 clearances
- Boston Scientific Corp — 1 clearance
- Boston Scientific Scimed, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/MUM)

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