Insufflator, Automatic Carbon-Dioxide for Endoscope

How Is FCX Classified?

Insufflator, Automatic Carbon-Dioxide For Endoscope is FDA product code FCX, 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. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 2 recalls under this product code since 2013. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Nonconforming Material/Component (1) and Use error (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.