Tubing and Tubing/Filter Fits

What Is It?

Tubing and tubing/filter fits are used when there is a need to distend the uterus by filling the uterine cavity with a liquid or gas to facilitate viewing with a hysteroscope.

What Is FDA Product Code NVT?

Tubing And Tubing/Filter Fits is FDA product code NVT, Class 1, 21 CFR 884.1700.

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 Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2024. None was by a company in China. The root cause the FDA records most often is Labeling design (1).

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