DeviceClearance

Product code SGN— Neurology

Neurolyser XR (NXR100)

Classification name
High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Device class
Class 2
Regulation
21 CFR 882.4420
Advisory panel
Neurology
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SGN under 21 CFR 882.4420, via openFDA

Market context for product code SGN

FDA has cleared 1 device under product code SGN, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SGN

Recent clearances under product code SGN

Data sourced from openFDA. This site is unofficial and independent of the FDA.