Choledochoscope and Accessories, Flexible/Rigid

What Is This Device?

to examine and perform procedures within the bile ducts. 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).

How Is FBN Classified?

Choledochoscope And Accessories, Flexible/Rigid is FDA product code FBN, 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 10 clearances under this code; the FDA took a median of 215 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Do the Recalls Say?

The FDA has recorded 9 recalls under this product code since 2016. None was by a company in China. 1 is Class I, the most serious grade.

The root causes the FDA records most often are Device Design (3), Nonconforming Material/Component (1) and Labeling design (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.