De Novo · Granted
GrantedNeurolyser XR (NXR100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fusmobile, Inc. · SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Granted on Nov 14, 2025 as a new device type through De Novo after a 203-day review.
- Decided
- Nov 14, 2025
- Review
- 203 days
- Class
- Class II
- Product code
- SGN
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SGN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SGN devicesSGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · SGN
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · SGN
Too few SGN 510(k)s in any year since 2007 to give a median.
Recalls per year · SGN
No recall names SGN since 2007.
Adverse event reports per year · SGN
No MAUDE report names SGN since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Neurolyser XR is indicated for the thermal ablation (neurolysis) of the medial branch nerve of the lumbar facet joint(s) (L1 to L5) for the treatment of chronic, facet-mediated low back pain of at least 6 months duration and a confirmed diagnosis based on positive response to lumbar branch block or denervation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN250015 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN250015: Neurolyser XR (NXR100).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN250015
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026