NWA
- Product code
- NWA
- Device name
- Prosthesis, Tracheal, Preformed/Molded
- Device class
- Class 2
- 21 CFR
- 21 CFR 878.3720
- Medical specialty
- General, Plastic Surgery
- Marketing pathway
- 510(K)
- Flag
- Implant
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 1 (direct download)
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
FDA classification definition
The device is intended to provide support to weakened or constricting airway walls.
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261541 | 2026-06-01 | VisionAir Solutions | VisionAir Enhanced Stock Stent | FDA |
| K243126 | 2024-10-29 | Novatech SA | TRACHEOBRONXANE DUMON® |
Official FDA classification page: NWA
Classification and pathway per current FDA publications. Data from openFDA (CC0).