510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250015Unknown

Neurolyser XR (NXR100)

Fusmobile, Inc, Alpharetta GA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250015 is the FDA 510(k) clearance record for Neurolyser XR (NXR100), a class II device, cleared for Fusmobile, Inc. on under FDA product code SGN (High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation). FDA's definition for product code SGN reads: "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". FDA records list one 510(k) clearance for Fusmobile, Inc. As of , FDA records show no recalls naming DEN250015.

Clearance record

Decision date
Received
(203 days to decision)
Product code
SGN High Intensity Focused Ultrasound System For Peripheral Neural Tissue Ablation
Regulation
21 CFR 882.4420
Device class
Class II
Review panel
Neurology
Applicant
Fusmobile, Inc. 6120 Windward Pkwy., Alpharetta GA
Third party review
No

Clearances, product code SGN

Trailing 12 months
1 clearance under product code SGN in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGN, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260