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Panels › Neurology › Product code SGN · Class 2

High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Regulation 882.4420

1510(k)s in 12 months (1 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
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Top companies in SGN

Company510(k)sRecalls
Fusmobile, Inc.10
Decided510(k)Device and applicantCode
Nov 14, 2025DEN250015Neurolyser XR (NXR100)
Fusmobile, Inc.
SGN

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