FDA 510(k)

Cellvizio I.V.E. system with Confocal Miniprobes

K-Number: K212322 · 2021-08-18

Decision Date2021-08-18

Product CodeOWN

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Cellvizio I.V.E. system with Confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2021-08-18 under approval number K212322. 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. system with Confocal Miniprobes?

Cellvizio I.V.E. system with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2021-08-18. It is manufactured by Mauna Kea Technologies. The 510(k) number is K212322.

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

Cellvizio I.V.E. system with Confocal Miniprobes received FDA 510(k) clearance on 2021-08-18, under approval number K212322.

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

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

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

The FDA product code for Cellvizio I.V.E. system 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 K193416Cellvizio I.V.E. 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.