Endoscopic Irrigation/Suction System

What Is This Device?

To supply sterile water, other solutions and/or suction to endoscopes during endoscopic procedures.

What Is FDA Product Code OCX?

Endoscopic Irrigation/Suction System is FDA product code OCX, 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 15 clearances under this code; the FDA took a median of 109 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.

5 were reviewed by an accredited third party.

What Has Gone Wrong With It?

The FDA has recorded 18 recalls under this product code since 2013. None was by a company in China. The root causes the FDA records most often are Process control (13), Component change control (2) and Device Design (1).

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