Probe, Radiofrequency Lesion

What Is FDA Product Code GXI?

Probe, Radiofrequency Lesion is FDA product code GXI, Class 2, 21 CFR 882.4725.

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 4 clearances under this code; the FDA took a median of 254 days from receipt to decision on them.

1 was reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 29 recalls under this product code since 2007. None was by a company in China. The root causes the FDA records most often are Error in labeling (6), Process control (3) and Labeling design (3).

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