Dilator, Catheter

How Is GCC Classified?

Dilator, Catheter is FDA product code GCC, 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 5 recalls under this product code since 2013. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.