NAJ · Class II · 21 CFR 870.3300

FDA Product Code NAJ: Agents, Embolic, For Treatment Of Uterine Fibroids

Leading manufacturers include Merit Medical Systems, Inc..

8
Total
8
Cleared
141d
Avg days
2002
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Agents, Embolic, For Treatment Of Uterine Fibroids Devices (Product Code NAJ)

8 devices
1–8 of 8

About Product Code NAJ - Regulatory Context

510(k) Submission Activity

8 total 510(k) submissions under product code NAJ since 2002, with 8 receiving FDA clearance (average review time: 141 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.

NAJ devices are reviewed by the Obstetrics & Gynecology panel. Browse all Obstetrics & Gynecology devices →