Battery-Powered Instruments Charged Through Sterile Barriers
Who Makes This Device Type in China?
The one Chinese manufacturer registered for this device type is based in Zhejiang. 1 is a contract manufacturer.
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
What Is This Device?
Battery-powered instruments intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissues (bones) and soft tissues. Accessories or attachments may include saw blades, drill chuck, pin driver, and reamer.
What Is FDA Product Code SAM?
Battery-Powered Instruments Charged Through Sterile Barriers is FDA product code SAM, Class 1, 21 CFR 878.4820.
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. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.