High Intensity Focused Ultrasound System for Peripheral Neural Tissue Ablation

What Is This Device?

A high intensity focused ultrasound system for peripheral neural tissue ablation is a device that transmits ultrasound energy to produce thermal lesions in a defined, targeted volume of peripheral nervous tissue through acoustic coupling.

What Is FDA Product Code SGN?

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation is FDA product code SGN, Class 2, 21 CFR 882.4420.

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.