Ligator, Esophageal

What Is FDA Product Code MND?

Ligator, Esophageal is FDA product code MND, Class 2, 21 CFR 876.4400.

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.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2010. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process change control (1), No Marketing Application (1) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.