510(k) K243126
K243126 is an FDA 510(k) premarket notification submitted by Novatech SA for the device "TRACHEOBRONXANE DUMON®". The FDA issued a decision of Substantially Equivalent on October 29, 2024. The device falls under product code NWA (Prosthesis, Tracheal, Preformed/Molded), a Class II device regulated under 21 CFR 878.3720. Novatech SA has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 29, 2024
- Date Received
- September 30, 2024
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Tracheal, Preformed/Molded
- Device Class
- Class II
- Regulation Number
- 878.3720
- Review Panel
- AN
- Submission Type
The device is intended to provide support to weakened or constricting airway walls.