510(k) DEN250015
DEN250015 is an FDA 510(k) premarket notification submitted by Fusmobile, Inc. for the device "Neurolyser XR (NXR100)". The FDA issued a decision of De Novo Granted on Nov 14, 2025. The device falls under product code SGN (High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation), a Class II device regulated under 21 CFR 882.4420.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- Nov 14, 2025
- Date Received
- Apr 25, 2025
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
- Device Class
- Class II
- Regulation Number
- 882.4420
- Review Panel
- NE
- Submission Type
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.