Ring (Wound Protector), Drape Retention, Internal

Who Makes This Device Type in China?

Chinese manufacturers registered for this device type are based in Jiangsu and Guangdong: 3 hold an FDA registration.

Guangzhou T.K Medical Instrument Co., Ltd. Guangdong, contract manufacturer
Jiangsu Medplus NON-Woven Manufacturer Co., Ltd. Jiangsu
Jiangsu Haize Medical Scientific Development Co., Ltd. Jiangsu

What Is FDA Product Code KGW?

Ring (Wound Protector), Drape Retention, Internal is FDA product code KGW, Class 2, 21 CFR 878.4370.

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.

Ring (Wound Protector), Drape Retention, Internal

Convertors

Vi-Drape Wound Protector

Ring (Wound Protector), Drape Retention, Internal

EZ Access™

Wound Protector/ Retractor

Ring (Wound Protector), Drape Retention, Internal

Alexis® Lighted Wound Protector-Retractor

The Alexis Lighted Wound Protector-Retractor is a device that allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with…

Ring (Wound Protector), Drape Retention, Internal