Media, Electroconductive

How Is GYB Classified?

Media, Electroconductive is FDA product code GYB, Class 2, 21 CFR 882.1275.

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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 4 clearances under this code; the FDA took a median of 107 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 10 recalls under this product code since 2019. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Process change control (1) and Process control (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.