Product Code: SGN
FDA class 2
21 CFR 882.4420
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Neurology
510(k)s
1
FEI Numbers
4
Registration Numbers
4
Unique Applicants
1
Years Active
—
Basic Information
- Product Code
- SGN
- Device Class
- FDA class 2
- Regulation Number
- 882.4420
- Medical Specialty
- Neurology
- Review Panel
- NE
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
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.
510(k) Clearance History
Loading...
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN250015 | Neurolyser XR (NXR100) | Nov 14, 2025 | Unknown | Fusmobile, Inc. |
FEI Numbers
This FDA classification entry is associated with 4 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 4 registration numbers. Click on an entry to view related FDA registrations.