LYA
- Product code
- LYA
- Device name
- Splint, Intranasal Septal
- Device class
- Class 1
- 21 CFR
- 21 CFR 874.4780
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 1
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 46 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K243655 | 2025-07-11 | Spirair, Inc. | TurbAlign |
Official FDA classification page: LYA
Classification and pathway per current FDA publications. Data from openFDA (CC0).