NWA
7 FDA 510(k) clearances · Product code
99 daysmedian time to decision
390 days90th percentile
7clearances measured
FDA profile
- Official device name
- Prosthesis, Tracheal, Preformed/Molded
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.3720
- Medical specialty
- General, Plastic Surgery
- Flags
- Implant
- FDA definition
- The device is intended to provide support to weakened or constricting airway walls.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| VisionAir Enhanced Stock Stent (K261541) | VisionAir Solutions | 2026-06-01 |
| TRACHEOBRONXANE™ DUMON® (K243126) | Novatech SA | 2024-10-29 |
| VisionAir Patient-Specific Airway Stent (K213969) | New Cos Inc. Dba Visionair Solutions | 2022-10-07 |
| Patient-Specific Airway Stent (K182743) | New Cos, Inc. | 2019-10-23 |
| ENDOXANE (K971509) | Novatech SA | 1997-08-21 |
| DUMON TRACHEOBRONCHIAL STENT (K894380) | Bryan Corp. | 1989-10-24 |
| HOOD TRACHEAL & TRACHEAL-BRONCHIAL PROSTHESES (K873742) | Hood Laboratories | 1987-10-01 |
Track NWA automatically
Every clearance here is in the API, with alerts when new ones post.