Not Cleared Direct

DEN250015 - Neurolyser XR (NXR100) (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN250015 · Fusmobile, Inc. · Neurology device
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Nov 2025
Decision
203d
Days
Class 2
Risk

DEN250015 is an FDA 510(k) submission (not cleared) for the Neurolyser XR (NXR100). Classified as High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation (product code SGN), Class II - Special Controls.

Submitted by Fusmobile, Inc. (Alpharetta, US). The FDA issued a Not Cleared (DENG) decision on November 14, 2025 after a review of 203 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4420 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Fusmobile, Inc. devices

Submission Details

510(k) Number DEN250015 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received April 25, 2025
Decision Date November 14, 2025
Days to Decision 203 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 148d · This submission: 203d
Pathway characteristics

Device Classification

Product Code SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4420
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.