Endoscopic Grasping/Cutting Instrument, Non-Powered

What Is It?

To manually grasp stones, tissues or other objects through an endoscope. To manipulate, sample or cut tissues through an endoscope.

What Is FDA Product Code OCZ?

Endoscopic Grasping/Cutting Instrument, Non-Powered is FDA product code OCZ, 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. The review can be done by an FDA-accredited third party, which is usually faster. Chinese applicants hold 2 clearances under this code; the FDA took a median of 185 days from receipt to decision on them.

What Has Gone Wrong With It?

The FDA has recorded 21 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Process control (17), Packaging process control (2) and Component design/selection (1).

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