SGN

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Product code

SGN

Device name

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Device class

Class 2

21 CFR

21 CFR 882.4420

Medical specialty

Neurology

Marketing pathway

510(K)

510(k) clearances (last 3 years)

1

FDA classification definition

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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-11-14.