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FDA 510(k)

Cellvizio I.V.E. with Confocal Miniprobes

K-Number: K193416 · 2020-02-28

ApplicantMauna Kea Technologies
Decision Date2020-02-28
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cellvizio I.V.E. with Confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2020-02-28 under approval number K193416. The device is classified under product code OWN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Cellvizio I.V.E. with Confocal Miniprobes?

Cellvizio I.V.E. with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Mauna Kea Technologies. The 510(k) number is K193416.

When was Cellvizio I.V.E. with Confocal Miniprobes approved by the FDA?

Cellvizio I.V.E. with Confocal Miniprobes received FDA 510(k) clearance on 2020-02-28, under approval number K193416.

What company makes Cellvizio I.V.E. with Confocal Miniprobes?

Cellvizio I.V.E. with Confocal Miniprobes is manufactured by Mauna Kea Technologies.

What is the FDA product code for Cellvizio I.V.E. with Confocal Miniprobes?

The FDA product code for Cellvizio I.V.E. with Confocal Miniprobes is OWN.

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 K180270Cellvizio 100 Series Systems with Confocal Miniprobes K183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes K191144Cellvizio 100 Series System with Confocal Miniprobes

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Related Devices (Code: OWN)

K152583KARL STORZ Endoscopic ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K160416CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal MiniprobesMauna Kea Technologies K172844Cellvizio 100 Series System with Confocal MiniprobesMauna Kea Technologies K171345Cellvizio 100 Series Systems with Confocal MiniprobesMauna Kea Technologies K171238KARL STORZ ICG Imaging SystemKARL STORZ Endoscopy-America, Inc. K162882KARL STORZ ICG Imaging 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.

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