FDA Product Code SHL:
Leading manufacturers include Tyto Care , Ltd..
1
Total
0
Cleared
330d
Avg days
2026
Since
Growing category -
1 submissions in the last 2 years
vs 0 in the prior period
FDA 510(k) Cleared SHL Devices (Product Code SHL)
1 devices
About Product Code SHL - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SHL since 2026, with 0 receiving FDA clearance (average review time: 330 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.
SHL devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →