Dislodger, Stone, Flexible

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Shanghai: 2 hold an FDA registration.

Innovex Medical Co., Ltd. Shanghai
Sterigenics Shanghai ETO Ltd. Shanghai, contract manufacturer

How Is FGO Classified?

Dislodger, Stone, Flexible is FDA product code FGO, Class 2, 21 CFR 876.4680.

What Does It Take to Sell It in the United States?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 3 recalls under this product code since 2003. None was by a company in China. The root cause the FDA records most often is Device Design (1).

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

Dislodger, Stone, Flexible

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