FDA 510(k)

MR Compatible Aspiration Kit

K-Number: K181731 · 2018-11-20

Decision Date2018-11-20

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MR Compatible Aspiration Kit is a medical device manufactured by Mri Interventions, Inc.. It received FDA 510(k) clearance on 2018-11-20 under approval number K181731. 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 MR Compatible Aspiration Kit?

MR Compatible Aspiration Kit is a medical device that received FDA 510(k) clearance on 2018-11-20. It is manufactured by Mri Interventions, Inc.. The 510(k) number is K181731.

When was MR Compatible Aspiration Kit approved by the FDA?

MR Compatible Aspiration Kit received FDA 510(k) clearance on 2018-11-20, under approval number K181731.

What company makes MR Compatible Aspiration Kit?

MR Compatible Aspiration Kit is manufactured by Mri Interventions, Inc..

What is the FDA product code for MR Compatible Aspiration Kit?

The FDA product code for MR Compatible Aspiration Kit is GWG.

Other Devices by Mri Interventions, Inc.

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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

View on FDA Database →

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