NWA — Prosthesis, Tracheal, Preformed/Molded Class II
FDA product code NWA covers "Prosthesis, Tracheal, Preformed/Molded", a Class II medical device regulated under 21 CFR 878.3720. Submissions are reviewed by the General, Plastic Surgery panel. Devices under this code are implants. At least 7 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- NWA
- Device Class
- Class II
- Regulation Number
- 878.3720
- Submission Type
- Review Panel
- AN
- Medical Specialty
- General, Plastic Surgery
- Implant
- Yes
Definition
The device is intended to provide support to weakened or constricting airway walls.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261541 | visionair solutions | VisionAir Enhanced Stock Stent | June 1, 2026 |
| K243126 | novatech | TRACHEOBRONXANE DUMON® | October 29, 2024 |
| K213969 | new cos inc. dba visionair solutions | VisionAir Patient-Specific Airway Stent | October 7, 2022 |
| K182743 | new cos | Patient-Specific Airway Stent | October 23, 2019 |
| K971509 | novatech | ENDOXANE | August 21, 1997 |
| K894380 | bryan | DUMON TRACHEOBRONCHIAL STENT | October 24, 1989 |
| K873742 | hood laboratories | HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES | October 1, 1987 |