Cleared Traditional

Monteris Medical NeuroBlate System

K240877 · Monteris Medical, · Neurology

Jun 2024

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K240877 is an FDA 510(k) clearance for the Monteris Medical NeuroBlate System, a Neurosurgical Laser With Mr Thermography (Class II — Special Controls, product code ONO), submitted by Monteris Medical, (Minnetonka, US). The FDA issued a Cleared decision on June 4, 2024, 67 days after receiving the submission on March 29, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K240877 FDA.gov
FDA Decision	Cleared 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

Device Classification

Product Code	ONO — Neurosurgical Laser With Mr Thermography
Device Class	Class II — 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.