Accessories, Cleaning, for Endoscope

What Is This Device?

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

What Is FDA Product Code FEB?

Accessories, Cleaning, For Endoscope is FDA product code FEB, Class 2, 21 CFR 876.1500.

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. 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 40 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Device Design (13), Nonconforming Material/Component (4) and Error in labeling (4).

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