ETD
- Product code
- ETD
- Device name
- Tube, Tympanostomy
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3880
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 5 (direct download)
- 510(k) clearances (all years, FDA)
- 116 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252436 | 2026-04-23 | Tusker Medical, Inc. | Tula Tympanostomy Tube Delivery Device | |
| K250256 | 2025-04-28 | Aventamed Dac | Solo+ Tympanostomy Tube Device (TTD), Solo+ TTD, Sol… | |
| K232702 | 2024-05-20 | Aventamed Dac | Solo+ Tympanostomy Tube Device (TTD) | |
| K233658 | 2024-02-16 | Biowy Corporation | Biowy Tym Tube (TT) | |
| K232059 | 2023-11-24 | Grace Medical, Inc. | Tympanostomy Tubes |
Official FDA classification page: ETD
Classification and pathway per current FDA publications. Data from openFDA (CC0).