ESW · Prosthesis, Esophageal
General, Plastic Surgery · 21 CFR 878.3610 · Class 2
Overview
| Product Code | ESW |
|---|---|
| Device Name | Prosthesis, Esophageal |
| Regulation | 21 CFR 878.3610 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 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 | HANAROSTENT Esophagus Upper (CCC) | M.I.Tech Co., Ltd. | Oct 30, 2025 | SESE |
| K243619 | Niti-S Esophageal Stent; Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 30, 2025 | SESE |
| K251265 | Resilience Fully Covered Esophageal Stent System | Merit Medical Systems, Inc. | Jul 23, 2025 | SESE |
| K233939 | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | Boston Scientific | Apr 29, 2024 | SESE |
| K233837 | Agile Esophageal Stent System | Boston Scientific Corporation | Apr 4, 2024 | SESE |
| K240522 | Esophageal TTS Stent | Taewoong Medical | Mar 22, 2024 | SESE |
| K223266 | Hilzo Esophageal Stents | Thoracent, Inc. | Jan 16, 2024 | SESE |
| K221482 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Jun 22, 2022 | SESE |
| K211960 | Agile Esophageal OTW Stent System | Boston Scientific Corporation | Nov 22, 2021 | SESE |
| K213251 | HANAROSTENT Esophagus Asymmetric (CCC) | M.I.Tech Co., Ltd. | Nov 18, 2021 | SESE |
| K211706 | Esophageal TTS Stent | Taewoong Medical Co., Ltd. | Oct 8, 2021 | SESE |
| K201160 | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | M.I.Tech Co., Ltd. | Jul 23, 2021 | SESE |
| K200860 | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | M.I.Tech Co., Ltd. | May 20, 2020 | SESE |
| K182910 | Segmented Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 29, 2019 | SESE |
| K180144 | Agile Esophageal Stent System | Boston Scientific Corporation | Sep 21, 2018 | SESE |
| K172813 | Esophageal Stent System | Micro-Tech (Nanjing) Co., Ltd. | May 18, 2018 | SESE |
| K162717 | Evolution Esophageal Stent System Partially Covered | Cook Ireland, Ltd. | Dec 21, 2016 | SESE |
| K130004 | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | Boston Scientific Corporation | Dec 6, 2013 | SESE |
| K123205 | ESOPHAGEAL TTS STENT | Taewoong Medical Co., Ltd. | Oct 9, 2013 | SESE |
| K120983 | 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
