Catheter, Cholangiography

What Is FDA Product Code GBZ?

Catheter, Cholangiography is FDA product code GBZ, Class 1, 21 CFR 878.4200.

How Does It Reach the US Market?

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 27 recalls under this product code since 2008. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (11), Labeling design (10) and Employee error (2).

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