FDA Product Code EWL: Prosthesis, Laryngeal (taub)
Leading manufacturers include Freudenberg Medical, LLC.
FDA 510(k) Cleared Prosthesis, Laryngeal (taub) Devices (Product Code EWL)
About Product Code EWL - Regulatory Context
510(k) Submission Activity
40 total 510(k) submissions under product code EWL since 1980, with 40 receiving FDA clearance (average review time: 112 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EWL have taken an average of 273 days to reach a decision - up from 108 days historically. Manufacturers should account for longer review timelines in current project planning.
EWL devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →