Gastroscope and Accessories, Flexible/Rigid

What Is It?

To examine or perform procedures in the stomach. For reusable, flexible endoscopes in this product code, validated reprocessing instructions and reprocessing validation data 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 FDS?

Gastroscope And Accessories, Flexible/Rigid is FDA product code FDS, 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. Chinese applicants hold 3 clearances under this code; the FDA took a median of 269 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 12 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Device Design (4), Nonconforming Material/Component (3) and Labeling Change Control (1).

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