What is FDA product code SGN?

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.

Neurology › SurgicalHigh Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation

Neurolyser XR

Name: Neurolyser XR
Brand: Neurolyser XR

The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray…

Registry build 21.09.26

The Neurolyser XR is intended for thermal ablation of neural tissue (neurolysis) at the bone tissue interface, using non- invasive high intensity focused ultrasound (HIFU) with X-ray guidance.

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

All of them in Hebei.

Chinese manufacturers registered for FDA product code SGN
Manufacturer	City	Province	Registered as	Device types
Hebei Tuosite Technology Co., Ltd.	Shijiazhuang	Hebei	Manufacturer	14
Hebei Lufen Tech Co., Limited	Xingtai	Hebei	Contract manufacturer	12

Record

Regulatory record for Neurolyser XR
Listed by	Fusmobile, Inc, United States
FDA product code	SGN
Device type	High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Device class	Class 2
Regulation	21 CFR 882.4420
Establishment	Manufacturer
510(k)	DEN250015
Record published	2025-12-10

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Handling environment temperature 10 to 40 °C; Storage environment temperature -10 to 57 °C
Packaging	Box

Catalogue Numbers

Catalogue numbers for Neurolyser XR
Catalogue number	Size	Status
NXR100		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Neurolyser XR DQA Assembly	Fusmobile, Inc	1
Neurolyser XR 30 mm Gel Pad	Fusmobile, Inc	1
Neurolyser XR 45 mm Gel Pad	Fusmobile, Inc	1

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
DEN250015	2025-11-14

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.