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NeuroBlate System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172881

by Monteris Medical,

Identifiers

510(k) Number
K172881 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 minimally invasive surgical device for robotic, cooled laser interstitial thermotherapy (LITT) using MR-guided ablation technology. It is designed specifically for use in the brain to provide precise, maximal lesion ablation in adult and pediatric patients.

The system is supplied as a reusable system and is indicated for use in neurosurgical settings. It operates under FDA 510(k) clearance (K172881) with product code GEX and is classified under the General, Plastic Surgery advisory committee. No claims about sterility, single-use status, MRI safety, sizes, or storage are made in the provided data.

Frequently asked questions

What is the NeuroBlate System used for?

The NeuroBlate System is designed for minimally invasive robotic, cooled laser interstitial thermotherapy (LITT) using MR-guided ablation technology to provide precise, maximal lesion ablation in the brain for adult and pediatric patients in neurosurgical settings.

Is the NeuroBlate System reusable or single-use?

The NeuroBlate System is supplied as a reusable system, meaning it is intended for multiple uses after appropriate reprocessing, as indicated in the device description.

What regulatory pathway was used for the NeuroBlate System?

The NeuroBlate System received FDA 510(k) clearance under submission K172881, which determines it to be substantially equivalent to a legally marketed predicate device.

In what clinical setting is the NeuroBlate System intended to be used?

The NeuroBlate System is indicated for use in neurosurgical settings, specifically for brain ablation procedures in both adult and pediatric patients.

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 Overview | LITT for Neurosurgeons - Monteris, NeuroBlate® System | Brain Laser Ablation | Monteris, Monteris Medical Neuroblate Instructions For Use Manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Monteris Medical,

Sources (1)

  • FDA 510(k) K172881 24 fields · synced Sep 28, 2026