Scale, Surgical Sponge

What Is FDA Product Code FQA?

Scale, Surgical Sponge is FDA product code FQA, Class 1, 21 CFR 880.2740.

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

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States. It is also exempt from most of the quality system regulation.

What Do the Recalls Say?

The FDA has recorded 1 recall under this product code since 2018. None was by a company in China. The root cause the FDA records most often is Use error (1).

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