Cleared Special

K260976 - NeuroBlate System

K260976 is an FDA 510(k) clearance for NeuroBlate System, manufactured by Monteris Medical,. The device is a Class 2 Neurology device with product code ONO cleared through the Special 510(k) pathway after a 30-day FDA review.

K260976 · Monteris Medical, · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
30d
Days
Class 2
Risk

K260976 is an FDA 510(k) clearance for the NeuroBlate System. Classified as Neurosurgical Laser With Mr Thermography (product code ONO), Class II - Special Controls.

Submitted by Monteris Medical, (Minnetonka, US). The FDA issued a Cleared decision on April 23, 2026 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 878.4810 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K260976

510(k) Number K260976 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 2026
Decision Date April 23, 2026
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 149d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

ONO Device Classification - Class 2, Special Controls

Product Code ONO Neurosurgical Laser With Mr Thermography
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4810
Definition Laser Device For Use To Necrotize Or Coagulate Soft Tissue Through Interstitial Irradition Or Thermal Therapy Under Mri Guidance And Real Time Mr Thermography In Neurosurgery.
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.

Regulatory Peers - ONO Neurosurgical Laser With Mr Thermography

All 7
Devices cleared under the same product code (ONO) and FDA review panel - the closest regulatory comparables to K260976.
NeuroBlate System
K262315 · Monteris Medical, · Sep 2026
Visualase Cooled Laser Applicator System (9735559)
K253391 · Medtronic Navigation, Inc. · Mar 2026
Mobile Laser Unit (1001-N2)
K251298 · Clinical Laserthermia Systems, AB · Sep 2025
Visualase V2 MRI-guided Laser Ablation System (9736422)
K250307 · Medtronic Navigation · May 2025
Monteris Medical NeuroBlate System
K240877 · Monteris Medical, · Jun 2024
TRANBERG Thermoguide Therapy System
K214125 · Clinical Laserthermia Systems, AB · Sep 2022
K260976 · NeuroBlate System
Download PDF FDA Summary Monteris Medical,