ETDClass II
Tube, Tympanostomy
21 CFR 874.3880 / Ear, Nose, Throat
ETD is the FDA product code for Tube, Tympanostomy, a class II device type, regulated under 21 CFR 874.3880. As of , FDA records hold 116 510(k) clearances under this code, the most recent dated , and 14 recalls.
Classification record
- Product code
- ETD
- Device name
- Tube, Tympanostomy
- Regulation
- 21 CFR 874.3880
- Device class
- Class II
- Review panel
- Ear, Nose, Throat
- Submission type
- 510(k)
- Implant
- Yes
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- No
- Ingested clearances
- 116
- Ingested recalls
- 14
Clearances, product code ETD
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 1 |
| 1978 | 5 |
| 1979 | 2 |
| 1980 | 4 |
| 1981 | 9 |
| 1982 | 7 |
| 1983 | 11 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 2 |
| 1987 | 3 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 2 |
| 1991 | 5 |
| 1993 | 5 |
| 1994 | 7 |
| 1995 | 5 |
| 1996 | 5 |
| 1997 | 9 |
| 1998 | 4 |
| 1999 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 1 |
| 2011 | 1 |
| 2014 | 1 |
| 2015 | 3 |
| 2017 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 2 |
| 2025 | 1 |
| 2026 | 1 |
Applicants with the most clearances
Product code ETD| Applicant | Clearances |
|---|---|
| Exmoor Plastics Limited | 16 |
| Treace Medical, Inc. | 9 |
| Xomed, Inc. | 7 |
| Grace Medical, Inc. | 5 |
| Micromed Development Corp. | 5 |
| Preceptis Medical, Inc | 5 |
| Xomed, Inc. | 5 |
| Richard'S Medical Equip., Inc. | 4 |
| Richards Medical Co., Inc. | 4 |
| Mednet Locator, Inc. | 3 |
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.