ESWClass II
Prosthesis, Esophageal
21 CFR 878.3610 / General, Plastic Surgery
ESW is the FDA product code for Prosthesis, Esophageal, a class II device type, regulated under 21 CFR 878.3610. As of , FDA records hold 60 510(k) clearances under this code, the most recent dated , and 67 recalls.
Classification record
- Product code
- ESW
- Device name
- Prosthesis, Esophageal
- Regulation
- 21 CFR 878.3610
- Device class
- Class II
- Review panel
- General, Plastic Surgery
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 60
- Ingested recalls
- 67
Clearances, product code ESW
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1987 | 1 |
| 1990 | 1 |
| 1991 | 2 |
| 1992 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 2 |
| 1998 | 2 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 2 |
| 2005 | 2 |
| 2006 | 1 |
| 2008 | 5 |
| 2009 | 3 |
| 2010 | 3 |
| 2011 | 1 |
| 2012 | 2 |
| 2013 | 2 |
| 2016 | 1 |
| 2018 | 2 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 4 |
| 2022 | 1 |
| 2024 | 4 |
| 2025 | 3 |
| 2026 | 1 |
Applicants with the most clearances
Product code ESW| Applicant | Clearances |
|---|---|
| Boston Scientific Corporation | 18 |
| Taewoong Medical Co., Ltd. | 8 |
| M.I.Tech Co Ltd | 6 |
| Alveolus, Inc. | 3 |
| Cook Ireland Ltd. | 3 |
| Wilson-Cook Medical Inc. | 3 |
| Cook Inc. | 2 |
| Hood Laboratories | 2 |
| Instent, Inc. | 2 |
| Merit Medical Systems, Inc. | 2 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.