FDA 510(k)

Neuroblade System

K-Number: K230125 · 2023-10-13

Decision Date2023-10-13

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Neuroblade System is a medical device manufactured by Clearmind Biomedical. It received FDA 510(k) clearance on 2023-10-13 under approval number K230125. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuroblade System?

Neuroblade System is a medical device that received FDA 510(k) clearance on 2023-10-13. It is manufactured by Clearmind Biomedical. The 510(k) number is K230125.

When was Neuroblade System approved by the FDA?

Neuroblade System received FDA 510(k) clearance on 2023-10-13, under approval number K230125.

What company makes Neuroblade System?

Neuroblade System is manufactured by Clearmind Biomedical.

What is the FDA product code for Neuroblade System?

The FDA product code for Neuroblade System is GWG.

Other Devices by Clearmind Biomedical

K201308Axonpen, Axonmonitor, Axonbox, Tablet K210251ClearPath Disposable Introducer

Related Devices (Code: GWG)

K161112KARL STORZ Flexible Video-Neuro-Endoscope SystemKARL STORZ Endoscopy-America, Inc. K152699Apollo SystemPenumbra, Inc. K170667QEVO System with KINEVO 900Carl Zeiss Meditec, AG K171332Artemis Neuro Evacuation DevicePenumbra, Inc. K170462KARL STORZ ShuntScopeKARL STORZ Endoscopy-America, Inc. K162880TIPCAM 1S 3D SystemKarl Storz Endoscopy America, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.