System, Imaging, Gastrointestinal, Wireless, Capsule

How Is NEZ Classified?

System, Imaging, Gastrointestinal, Wireless, Capsule is FDA product code NEZ, Class 2, 21 CFR 876.1300.

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 1 clearance under this code; the FDA took 183 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 6 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Device Design (2), Employee error (2) and Process control (1).

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