SGN — High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation Class II
FDA product code SGN covers "High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation", a Class II medical device regulated under 21 CFR 882.4420. Submissions are reviewed by the Neurology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SGN
- Device Class
- Class II
- Regulation Number
- 882.4420
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- No
Definition
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN250015 | Fusmobile | Neurolyser XR (NXR100) | Nov 14, 2025 |