Agents, Embolic, for Treatment of Uterine Fibroids

How Is NAJ Classified?

Agents, Embolic, For Treatment Of Uterine Fibroids is FDA product code NAJ, Class 2, 21 CFR 870.3300.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 1 clearance under this code; the FDA took 271 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2009. None was by a company in China. The root cause the FDA records most often is Process design (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.