FDA Product Code ETD: Tube, Tympanostomy
Leading manufacturers include Aventamed Dac, Grace Medical, Inc. and Biowy Corporation.
FDA 510(k) Cleared Tube, Tympanostomy Devices (Product Code ETD)
About Product Code ETD - Regulatory Context
510(k) Submission Activity
116 total 510(k) submissions under product code ETD since 1976, with 116 receiving FDA clearance (average review time: 85 days).
Submission volume has remained relatively stable over the observed period, with 3 submissions in the last 24 months.
FDA Review Time
Recent submissions under ETD have taken an average of 204 days to reach a decision - up from 82 days historically. Manufacturers should account for longer review timelines in current project planning.
ETD devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →