Needle, Fistula

How Is FIE Classified?

Needle, Fistula is FDA product code FIE, Class 2, 21 CFR 876.5540.

How Does It Reach the US Market?

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 2 clearances under this code; the FDA took a median of 231 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 7 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Labeling mix-ups (2) and Employee error (1).

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