Endoscopic Video Imaging System/Component, Gastroenterology-Urology

What Is This Device?

To allow for visualization of body cavities through an endoscope by projecting images to a monitor.

How Is FET Classified?

Endoscopic Video Imaging System/Component, Gastroenterology-Urology is FDA product code FET, 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 4 clearances under this code; the FDA took a median of 126 days from receipt to decision on them. 1 was reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 8 recalls under this product code since 2015. None was by a company in China. The root cause the FDA records most often is Device Design (3).

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