Stents, Drains and Dilators for the Biliary Ducts

What Is FDA Product Code FGE?

Stents, Drains And Dilators For The Biliary Ducts is FDA product code FGE, Class 2, 21 CFR 876.5010.

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 11 clearances under this code; the FDA took a median of 188 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 450 recalls under this product code since 2002. None was by a company in China. The root causes the FDA records most often are Process control (100), Packaging process control (57) and Employee error (25).

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