Cystoscope and Accessories, Flexible/Rigid

What Is This Device?

To examine and perform procedures within the urinary tract. 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 FAJ Classified?

Cystoscope And Accessories, Flexible/Rigid is FDA product code FAJ, 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 11 clearances under this code; the FDA took a median of 111 days from receipt to decision on them. 2 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

What Has Gone Wrong With It?

The FDA has recorded 22 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Equipment maintenance (7), Packaging (3) and Device Design (1).

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