Endoscopic Access Overtube, Gastroenterology-Urology

What Is This Device?

To facilitate passage and aid advancement of endoscopes into the body, especially in cases of repeated intubation.

How Is FED Classified?

Endoscopic Access Overtube, Gastroenterology-Urology is FDA product code FED, Class 2, 21 CFR 876.1500.

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 18 clearances under this code; the FDA took a median of 127 days from receipt to decision on them. 2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2004. None was by a company in China. 5 are Class I, the most serious grade.

The root causes the FDA records most often are Labeling False and Misleading (4), Component design/selection (3) and Equipment maintenance (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.