Colonoscope and Accessories, Flexible/Rigid

What Is This Device?

To examine or perform procedures in the colon or rectum 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 FDF?

Colonoscope And Accessories, Flexible/Rigid is FDA product code FDF, 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. Chinese applicants hold 4 clearances under this code; the FDA took a median of 162 days from receipt to decision on them.

What Do the Recalls Say?

The FDA has recorded 25 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 (7), Device Design (6) and Nonconforming Material/Component (5).

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