Knife, Surgical
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Guangdong, Zhejiang and Beijing, and 3 other provinces: 8 hold an FDA registration.
- Bothwin (Beijing) Medical Technology Co., Ltd. Beijing
- Foshan Cicada Dental Instrument Co., Ltd. Guangdong
- Hangzhou Kangji Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Hangzhou Tonglu Shikonghou Medical Instrument Co., Ltd. Zhejiang, contract manufacturer
- Nanjing J SUN Healthcare Co., Ltd. Jiangsu
- Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai, contract manufacturer
- Shenzhen Soga Technology Co., Ltd. Guangdong
- Xinhua Surgical Instrument Co., Ltd. Shandong
What Is FDA Product Code EMF?
Knife, Surgical is FDA product code EMF, 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 Has Gone Wrong With It?
The FDA has recorded 9 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 (5), Packaging process control (1) and Nonconforming Material/Component (1).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.