FDA Product Code LXV: Apparatus, Vestibular Analysis
Leading manufacturers include Interacoustics A/S and Ultrathera Technologies, Inc..
22
Total
22
Cleared
154d
Avg days
1977
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Apparatus, Vestibular Analysis Devices (Product Code LXV)
22 devices
Cleared
Apr 27, 2022
GyroStim
Ultrathera Technologies, Inc.
Ear, Nose, Throat
90d
Cleared
Aug 12, 2020
Orion
Interacoustics A/S
Ear, Nose, Throat
163d
Cleared
May 27, 2020
TRV
Interacoustics A/S
Ear, Nose, Throat
246d
About Product Code LXV - Regulatory Context
510(k) Submission Activity
22 total 510(k) submissions under product code LXV since 1977, with 22 receiving FDA clearance (average review time: 154 days).
Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.
LXV devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →