FDA Product Code NWA: Prosthesis, Tracheal, Preformed/molded
The Device Is Intended To Provide Support To Weakened Or Constricting Airway Walls.
Leading manufacturers include New Cos Inc. Dba Visionair Solutions and Novatech SA.
FDA 510(k) Cleared Prosthesis, Tracheal, Preformed/molded Devices (Product Code NWA)
About Product Code NWA - Regulatory Context
510(k) Submission Activity
6 total 510(k) submissions under product code NWA since 1987, with 6 receiving FDA clearance (average review time: 157 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under NWA have taken an average of 29 days to reach a decision - down from 183 days historically, suggesting improved FDA processing for this classification.
NWA devices are reviewed by the Anesthesiology panel. Browse all Anesthesiology devices →