FDA 510(k)

Cellvizio 100 Series Systems with Confocal Miniprobes

K-Number: K180270 · 2018-05-22

Decision Date2018-05-22

Product CodeGWG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Cellvizio 100 Series Systems with Confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2018-05-22 under approval number K180270. 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 Cellvizio 100 Series Systems with Confocal Miniprobes?

Cellvizio 100 Series Systems with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2018-05-22. It is manufactured by Mauna Kea Technologies. The 510(k) number is K180270.

When was Cellvizio 100 Series Systems with Confocal Miniprobes approved by the FDA?

Cellvizio 100 Series Systems with Confocal Miniprobes received FDA 510(k) clearance on 2018-05-22, under approval number K180270.

What company makes Cellvizio 100 Series Systems with Confocal Miniprobes?

Cellvizio 100 Series Systems with Confocal Miniprobes is manufactured by Mauna Kea Technologies.

What is the FDA product code for Cellvizio 100 Series Systems with Confocal Miniprobes?

The FDA product code for Cellvizio 100 Series Systems with Confocal Miniprobes is GWG.

Related Clinical Trials

NCT01931579 Assessment of Probe Based Confocal Laser Endo-microscopy for In-vivo Diagnosis of Peripheral Lung Nodules and Masses. COMPLETED

Other Devices by Mauna Kea Technologies

K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes K172844Cellvizio 100 Series System with Confocal Miniprobes K171345Cellvizio 100 Series Systems with Confocal Miniprobes K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes K193416Cellvizio I.V.E. with Confocal Miniprobes K191144Cellvizio 100 Series System with Confocal Miniprobes

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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.