Biliary Catheter for Stone Removal That May Also Allow for Irrigation and Contrast Injection

How Is GCA Classified?

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection is FDA product code GCA, Class 2, 21 CFR 876.5010.

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 135 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2002. None was by a company in China. A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.