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
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.