Curette, Surgical, General Use

Who Makes This Device Type in China?

4 manufacturers in China hold an FDA registration for this device type, concentrated in Shanghai, Jiangsu and Shandong. 2 of them are contract manufacturers, able to build to a buyer’s own specification.

Jiangsu Ideal Medical Science & Technology Co., Ltd. Jiangsu, contract manufacturer
Shanghai KiNETIC Medical Co Ltd Shanghai, contract manufacturer
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
Xinhua Surgical Instrument Co., Ltd. Shandong

How Is FZS Classified?

Curette, Surgical, General Use is FDA product code FZS, Class 1, 21 CFR 878.4800.

How Does It Reach the US Market?

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 Do the Recalls Say?

The FDA has recorded 3 recalls under this product code since 2011. None was by a company in China. The root causes the FDA records most often are Process change control (1) 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.

Curette, Surgical, General Use

Curette, Surgical, General Use

Who Makes This Device Type in China?

How Is FZS Classified?

How Does It Reach the US Market?

What Do the Recalls Say?

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Where China Actually Supplies