Cleared Traditional

K240877 - Monteris Medical NeuroBlate System (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K240877 · Monteris Medical, · Neurology device
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
67d
Days
Class 2
Risk

K240877 is an FDA 510(k) clearance for the Monteris Medical 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 June 4, 2024 after a review of 67 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Monteris Medical, devices

Submission Details

510(k) Number K240877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2024
Decision Date June 04, 2024
Days to Decision 67 days
Submission Type Traditional
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
81d faster than avg
Panel avg: 148d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (ONO) and FDA review panel - the closest regulatory comparables to K240877.
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