510(k) DEN250015
- Device
- Neurolyser XR (NXR100)
- Applicant
- Fusmobile, Inc.
- 510(k) number
- DEN250015
- Product code
- SGN
- Decision
- Unknown (DENG)
- Decision date
- 2025-11-14
- Date received
- 2025-04-25
- Regulation
- 882.4420
- Classification name
- High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
- Medical specialty
- Neurology
- Review panel
- Neurology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Ron Aginsky
- Address
- 6120 Windward Pkwy. Suite 210 Alpharetta GA US 30005 30005
FDA Registration Numbers#
- 3043149902
- 3031233199
- 3043012074
- 3019585303
Source Documents#
510(k) summary PDF not indicated by FDA