FDA product code ESW: Prosthesis, Esophageal
ESW is the FDA product code for prosthesis, esophageal. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 60 510(k) submissions under ESW, 9 in the last five years, from 24 different applicants. The average 510(k) review took 163 days (median 104); 122 days on average over the last three years. FDA has posted 67 recalls for ESW devices, 31 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Prosthesis, Esophageal |
| Device class | Class II |
| Regulation | 21 CFR 878.3610 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for ESW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 244 |
| 2019 | 1 | 224 |
| 2020 | 1 | 49 |
| 2021 | 4 | 194 |
| 2022 | 1 | 30 |
| 2024 | 4 | 184 |
| 2025 | 3 | 154 |
| 2026 | 1 | 28 |
Compare with all 510(k) review times · Search every ESW clearance
Top ESW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Boston Scientific Corporation | 9 | 2026-07-10 |
| Taewoong Medical Co., Ltd. | 7 | 2025-10-30 |
| M.I.Tech Co., Ltd. | 6 | 2025-10-30 |
| Boston Scientific Corp | 5 | 2008-02-27 |
| Cook Ireland, Ltd. | 3 | 2016-12-21 |
19 more applicants have ESW clearances. See the full list in Caduvo.
Most recent ESW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261978 | Boston Scientific Corporation | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent System | 2026-07-10 | 28 |
| K243619 | Taewoong Medical Co., Ltd. | Niti-S Esophageal Stent; Esophageal TTS Stent | 2025-10-30 | 342 |
| K253327 | M.I.Tech Co., Ltd. | HANAROSTENT Esophagus Upper (CCC) | 2025-10-30 | 30 |
| K251265 | Merit Medical Systems, Inc. | Resilience Fully Covered Esophageal Stent System | 2025-07-23 | 90 |
| K233939 | Boston Scientific | Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System | 2024-04-29 | 137 |
Recalls for ESW devices
67 product recalls in 6 recall events; 31 initiated in the last five years and 31 still open. Most recent: 2024-08-01.
| Year | Recalls |
|---|---|
| 2019 | 1 |
| 2024 | 31 |
Frequently asked questions
What is FDA product code ESW?
ESW is the FDA product code for prosthesis, esophageal. It is a Class II device, regulated under 21 CFR 878.3610 and reviewed by the Gastroenterology and Urology panel.
What device class is ESW?
Class II, regulation 21 CFR 878.3610. Typical premarket route: 510(k).
How long does a 510(k) take for product code ESW?
Across 60 cleared submissions the average was 163 days from receipt to decision (median 104).
Which companies have the most ESW clearances?
Boston Scientific Corporation (9); Taewoong Medical Co., Ltd. (7); M.I.Tech Co., Ltd. (6); Boston Scientific Corp (5); Cook Ireland, Ltd. (3).
Have ESW devices been recalled?
Yes: 67 product recalls across 6 recall events; the most recent began 2024-08-01.
Next steps
- Run an FDA pathway report with predicate devices for product code ESW
- Run a recall and safety report across every ESW manufacturer
- Watch product code ESW for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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