Ureteroscope and Accessories, Flexible/Rigid

What Is This Device?

To perform various diagnostic and therapeutic 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).

What Is FDA Product Code FGB?

Ureteroscope And Accessories, Flexible/Rigid is FDA product code FGB, 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 31 clearances under this code; the FDA took a median of 136 days from receipt to decision on them. 6 went the Special 510(k) route, the one for a change to the applicant’s own cleared device.

2 were reviewed by an accredited third party.

What Do the Recalls Say?

The FDA has recorded 28 recalls under this product code since 2016. None was by a company in China. The root causes the FDA records most often are Labeling Change Control (14), Device Design (6) and Nonconforming Material/Component (3).

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