510(k) DEN250015 ยท SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Neurolyser XR (NXR100)
| Applicant | Fusmobile, Inc., Alpharetta GA, US |
| Decision | Unknown, Nov 14, 2025 |
| Received | Apr 25, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250015
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.