Gastrointestinal Tubes With Enteral Specific Connectors

What Is It?

To facilitate enteral specific connections.

What Is FDA Product Code PIF?

Gastrointestinal Tubes With Enteral Specific Connectors is FDA product code PIF, Class 2, 21 CFR 876.5980.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 3 clearances under this code; the FDA took a median of 177 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 112 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Device Design (105), Process design (2) and Process control (1).

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