Endoscopic Cytology Brush

What Is It?

To collect cells for cytological evaluation.

What Is FDA Product Code FDX?

Endoscopic Cytology Brush is FDA product code FDX, 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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 190 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 5 recalls under this product code since 2006. None was by a company in China. The root causes the FDA records most often are Process control (2), No Marketing Application (1) and Labeling False and Misleading (1).

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