SGN · Class II · 21 CFR 882.4420

FDA Product Code SGN: High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

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.

Leading manufacturers include Fusmobile, Inc..

1
Total
0
Cleared
203d
Avg days
2025
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period

FDA 510(k) Cleared High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation Devices (Product Code SGN)

1 devices
1–1 of 1
Not Cleared Nov 14, 2025
Neurolyser XR (NXR100)
DEN250015
Fusmobile, Inc.
Neurology · 203d

About Product Code SGN - Regulatory Context

510(k) Submission Activity

1 total 510(k) submissions under product code SGN since 2025, with 0 receiving FDA clearance (average review time: 203 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

SGN devices are reviewed by the Neurology panel. Browse all Neurology devices →