De Novo DEN250015
- Device
- Neurolyser XR (NXR100)
- Contact
- ron aginsky
- De Novo number
- DEN250015
- Product code
- SGN
- Regulation
- 882.4420
- Classification name
- high intensity focused ultrasound system for peripheral neural tissue ablation
- Decision
- granted (DENG)
- Decision date
- 2025-11-14
- Date received
- 2025-04-25
- Classification advisory
- Neurology
- Review advisory
- Neurology
- Type
- Direct
Current FDA Classification#
- Product code
- SGN
- Device name
- High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
- Medical specialty
- Neurology
- Device class
- 2
- Regulation
- 882.4420
- Implant
- N
- Life sustain/support
- N