FDA Product Code EMX: Balloon, Epistaxis
Leading manufacturers include Hemostasis, LLC.
47
Total
47
Cleared
107d
Avg days
1978
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Balloon, Epistaxis Devices (Product Code EMX)
47 devices
About Product Code EMX - Regulatory Context
510(k) Submission Activity
47 total 510(k) submissions under product code EMX since 1978, with 47 receiving FDA clearance (average review time: 107 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
EMX devices are reviewed by the Ear, Nose, Throat panel. Browse all Ear, Nose, Throat devices →