Prosthesis, Esophageal

What Is FDA Product Code ESW?

Prosthesis, Esophageal is FDA product code ESW, Class 2, 21 CFR 878.3610.

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 233 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 67 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Process control (40), Device Design (16) and Error in labeling (1).

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