Applier, Hemostatic Clip

What Is FDA Product Code HBT?

Applier, Hemostatic Clip is FDA product code HBT, Class 1, 21 CFR 878.4800.

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 14 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging change control (2), Packaging process control (1) and Nonconforming Material/Component (1).

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