ESW
- Product code
- ESW
- Device name
- Prosthesis, Esophageal
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3610
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 60
510(k) clearances, last 3 years (8)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261978 | 2026-07-10 | Boston Scientific Corporation | WallFlex Esophageal Stent System;Agile Esophageal Ov | |
| K243619 | 2025-10-30 | Taewoong Medical Co., Ltd. | Niti-S Esophageal Stent; Esophageal TTS Stent | |
| K253327 | 2025-10-30 | M.I.Tech Co., Ltd. | HANAROSTENT Esophagus Upper (CCC) | |
| K251265 | 2025-07-23 | Merit Medical Systems, Inc. | Resilience Fully Covered Esophageal Stent System | |
| K233939 | 2024-04-29 | Boston Scientific | Ultraflex Esophageal NG Stent System; WallFlex Esoph | |
| K233837 | 2024-04-04 | Boston Scientific Corporation | Agile Esophageal Stent System | |
| K240522 | 2024-03-22 | Taewoong Medical | Esophageal TTS Stent | |
| K223266 | 2024-01-16 | Thoracent, Inc. | Hilzo Esophageal Stents |
Official FDA classification page: ESW
Classification and pathway per current FDA publications. Data from openFDA (CC0).