Endoscopic Ultrasound System, Gastroenterology-Urology

What Is It?

To provide ultrasonic visualization of body cavities that can be accessed by endoscope. 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 ODG Classified?

Endoscopic Ultrasound System, Gastroenterology-Urology is FDA product code ODG, 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 90 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 10 recalls under this product code since 2015. 2 were by a company in China. The root causes the FDA records most often are Device Design (8) and Error in labeling (2).

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