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) → ESW — Prosthesis, Esophageal

# ESW · Prosthesis, Esophageal

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

**Canonical URL:** https://fda.innolitics.com/productcode/ESW

## Overview

- **Product Code:** ESW
- **Device Name:** Prosthesis, Esophageal
- **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 (20 of 59)

Showing 20 most recent of 59 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253327](/device/K253327.md) | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | Oct 30, 2025 | SESE |
| [K243619](/device/K243619.md) | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 30, 2025 | SESE |
| [K251265](/device/K251265.md) | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | Jul 23, 2025 | SESE |
| [K233939](/device/K233939.md) | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | Apr 29, 2024 | SESE |
| [K233837](/device/K233837.md) | Agile Esophageal Stent System | Boston Scientific Corporation | Apr 4, 2024 | SESE |
| [K240522](/device/K240522.md) | Esophageal TTS Stent | Taewoong Medical | Mar 22, 2024 | SESE |
| [K223266](/device/K223266.md) | Hilzo Esophageal Stents | Thoracent, Inc. | Jan 16, 2024 | SESE |
| [K221482](/device/K221482.md) | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Jun 22, 2022 | SESE |
| [K211960](/device/K211960.md) | Agile Esophageal OTW Stent System | Boston Scientific Corporation | Nov 22, 2021 | SESE |
| [K213251](/device/K213251.md) | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | Nov 18, 2021 | SESE |
| [K211706](/device/K211706.md) | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 8, 2021 | SESE |
| [K201160](/device/K201160.md) | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | Jul 23, 2021 | SESE |
| [K200860](/device/K200860.md) | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | May 20, 2020 | SESE |
| [K182910](/device/K182910.md) | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 29, 2019 | SESE |
| [K180144](/device/K180144.md) | Agile Esophageal Stent System | Boston Scientific Corporation | Sep 21, 2018 | SESE |
| [K172813](/device/K172813.md) | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 18, 2018 | SESE |
| [K162717](/device/K162717.md) | Evolution Esophageal Stent System – Partially Covered | Cook Ireland, Ltd. | Dec 21, 2016 | SESE |
| [K130004](/device/K130004.md) | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | Dec 6, 2013 | SESE |
| [K123205](/device/K123205.md) | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | Oct 9, 2013 | SESE |
| [K120983](/device/K120983.md) | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | May 2, 2012 | SESE |

## Top Applicants

- Boston Scientific Corporation — 8 clearances
- Taewoong Medical Co., Ltd. — 7 clearances
- M.I.Tech Co., Ltd. — 6 clearances
- Boston Scientific Corp — 5 clearances
- Alveolus, Inc. — 3 clearances

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**Source:** [https://fda.innolitics.com/productcode/ESW](https://fda.innolitics.com/productcode/ESW)

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