System, Ablation, Microwave and Accessories

What Is FDA Product Code NEY?

System, Ablation, Microwave And Accessories is FDA product code NEY, Class 2, 21 CFR 878.4400.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 10 clearances under this code; the FDA took a median of 117 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 27 recalls under this product code since 2016. 1 was by a company in China. The root causes the FDA records most often are Device Design (11), Software design (4) and Nonconforming Material/Component (4).

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