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/submissions/SU/subpart-d%E2%80%94prosthetic-devices/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](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K253327.md) | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | Oct 30, 2025 | SESE | | [K243619](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K243619.md) | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 30, 2025 | SESE | | [K251265](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K251265.md) | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | Jul 23, 2025 | SESE | | [K233939](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K233939.md) | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | Apr 29, 2024 | SESE | | [K233837](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K233837.md) | Agile Esophageal Stent System | Boston Scientific Corporation | Apr 4, 2024 | SESE | | [K240522](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K240522.md) | Esophageal TTS Stent | Taewoong Medical | Mar 22, 2024 | SESE | | [K223266](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K223266.md) | Hilzo Esophageal Stents | Thoracent, Inc. | Jan 16, 2024 | SESE | | [K221482](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K221482.md) | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Jun 22, 2022 | SESE | | [K211960](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K211960.md) | Agile Esophageal OTW Stent System | Boston Scientific Corporation | Nov 22, 2021 | SESE | | [K213251](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K213251.md) | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | Nov 18, 2021 | SESE | | [K211706](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K211706.md) | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 8, 2021 | SESE | | [K201160](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K201160.md) | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | Jul 23, 2021 | SESE | | [K200860](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K200860.md) | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | May 20, 2020 | SESE | | [K182910](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K182910.md) | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 29, 2019 | SESE | | [K180144](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K180144.md) | Agile Esophageal Stent System | Boston Scientific Corporation | Sep 21, 2018 | SESE | | [K172813](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K172813.md) | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 18, 2018 | SESE | | [K162717](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K162717.md) | Evolution Esophageal Stent System – Partially Covered | Cook Ireland, Ltd. | Dec 21, 2016 | SESE | | [K130004](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K130004.md) | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | Dec 6, 2013 | SESE | | [K123205](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/K123205.md) | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | Oct 9, 2013 | SESE | | [K120983](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW/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 - Wilson-Cook Medical, Inc. — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW](https://fda.innolitics.com/submissions/SU/subpart-d%E2%80%94prosthetic-devices/ESW) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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