FDA Product Code MIX: System, Vocal Cord Medialization
Leading manufacturers include Sofregen Medical.
17
Total
17
Cleared
111d
Avg days
1997
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared System, Vocal Cord Medialization Devices (Product Code MIX)
17 devices
About Product Code MIX - Regulatory Context
510(k) Submission Activity
17 total 510(k) submissions under product code MIX since 1997, with 17 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
MIX devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →