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NeuroBlate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K141983

by Monteris Medical Corp.

Identifiers

510(k) Number
K141983 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The NeuroBlate System is a robotic MR-guided laser ablation tool designed specifically for use in the brain. It provides minimally invasive surgical treatment using cooled laser interstitial thermotherapy technology for brain tumors, radiation necrosis, and drug-resistant epilepsy in adult and pediatric patients.

The system is intended for planning and monitoring thermal therapies under MRI visualization, providing MRI-based trajectory planning. It is supplied by Monteris Medical Corp. and has FDA 510(k) clearance with product code GEX. The device is used in a neurosurgical setting and offers precise brain lesion ablation without the invasiveness of open procedures.

Frequently asked questions

What is the NeuroBlate System used for?

The NeuroBlate System is a robotic MR-guided laser ablation tool designed for minimally invasive surgical treatment of brain tumors, radiation necrosis, and drug-resistant epilepsy in both adult and pediatric patients, using cooled laser interstitial thermotherapy technology.

How is the NeuroBlate System supplied?

The NeuroBlate System is supplied by Monteris Medical Corp. and is intended for use in a neurosurgical setting, providing MRI-based trajectory planning and monitoring of thermal therapies under MRI visualization.

What is the regulatory status of the NeuroBlate System?

The NeuroBlate System has FDA 510(k) clearance with product code GEX, received on August 11, 2014, after being filed on July 21, 2014, with decision code SESE indicating it is substantially equivalent.

Is the NeuroBlate System reusable or single-use?

The device information does not specify whether the NeuroBlate System is reusable or single-use, as this detail is not included in the provided device data.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: NeuroBlate® System | Brain Laser Ablation | Monteris, NeuroBlate System Overview | LITT for Neurosurgeons - Monteris, NeuroBlate System (K260976) — FDA 510 (k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monteris Medical Corp.

Sources (1)

  • FDA 510(k) K141983 24 fields · synced Sep 22, 2026