EMX · Class I · 21 CFR 874.4100

FDA Product Code EMX: Balloon, Epistaxis

Leading manufacturers include Hemostasis, LLC and Edward Weck, Inc..

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
1–24 of 47
Cleared Nov 14, 2022
PosiSep X BAM Hemostat Dressing/Intranasal Splint
K220326
Hemostasis, LLC
Ear, Nose, Throat · 283d
Cleared Feb 21, 1980
NASOSTAT
K800175
Edward Weck, Inc.
Ear, Nose, Throat · 24d

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.