ESW — Prosthesis, Esophageal Class II
FDA product code ESW covers "Prosthesis, Esophageal", a Class II medical device regulated under 21 CFR 878.3610. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- ESW
- Device Class
- Class II
- Regulation Number
- 878.3610
- Submission Type
- Review Panel
- GU
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261978 | boston scientific corporation | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent Syst | July 10, 2026 |
| K243619 | taewoong medical co | Niti-S Esophageal Stent; Esophageal TTS Stent | October 30, 2025 |
| K253327 | m.i.tech co | HANAROSTENT Esophagus Upper (CCC) | October 30, 2025 |
| K251265 | merit medical systems | Resilience Fully Covered Esophageal Stent System | July 23, 2025 |
| K233939 | boston scientific | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | April 29, 2024 |
| K233837 | boston scientific corporation | Agile Esophageal Stent System | April 4, 2024 |
| K240522 | taewoong medical | Esophageal TTS Stent | March 22, 2024 |
| K223266 | thoracent | Hilzo Esophageal Stents | January 16, 2024 |
| K221482 | taewoong medical co | Esophageal TTS Stent | June 22, 2022 |
| K211960 | boston scientific corporation | Agile Esophageal OTW Stent System | November 22, 2021 |
| K213251 | m.i.tech co | HANAROSTENT Esophagus Asymmetric (CCC) | November 18, 2021 |
| K211706 | taewoong medical co | Esophageal TTS Stent | October 8, 2021 |
| K201160 | m.i.tech co | HANAROSTENT Esophagus (CCC), HANAROSTENT Esophagus (NCN) | July 23, 2021 |
| K200860 | m.i.tech co | HANAROSTENT Esophagus TTS (CCC), HANAROSTENT Esophagus TTS (NCN) | May 20, 2020 |
| K182910 | micro-tech (nanjing) co | Segmented Esophageal Stent System | May 29, 2019 |
| K180144 | boston scientific corporation | Agile Esophageal Stent System | September 21, 2018 |
| K172813 | micro-tech (nanjing) co | Esophageal Stent System | May 18, 2018 |
| K162717 | cook ireland | Evolution Esophageal Stent System Partially Covered | December 21, 2016 |
| K130004 | boston scientific corporation | ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM | December 6, 2013 |
| K123205 | taewoong medical co | ESOPHAGEAL TTS STENT | October 9, 2013 |