Unit, Electrosurgical, Endoscopic (With or Without Accessories), Reprocessed
Which Manufacturers in China Make This?
7 manufacturers in China hold an FDA registration for this device type, concentrated in Zhejiang, Jiangsu and Beijing, and 1 other province.
- Anrei Medical (Hangzhou) Co., Ltd. Zhejiang
- Beijing Zksk Technology Co., Ltd. Beijing, contract manufacturer
- Hebei Lufen Tech Co., Limited Hebei, contract manufacturer
- Hangzhou AGS MedTech Co., Ltd. Zhejiang
- Jiangsu Vedkang Medical Science and Technology Co., Ltd. Jiangsu
- Micro-Tech (Nanjing) Co., Ltd. Jiangsu, contract manufacturer
- Zhejiang Soudon Medical Technology Co., Ltd. Zhejiang
How Is KNS Classified?
Unit, Electrosurgical, Endoscopic (With Or Without Accessories) is FDA product code KNS, Class 2, 21 CFR 876.4300.
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 8 clearances under this code; the FDA took a median of 222 days from receipt to decision on them.
What Has Gone Wrong With It?
The FDA has recorded 121 recalls under this product code since 2003. None was by a company in China. 6 are Class I, the most serious grade.
The root causes the FDA records most often are Process control (59), Packaging process control (37) and Device Design (3). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.