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FDA 510(k)

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes

K-Number: K160416 · 2016-05-20

ApplicantMauna Kea Technologies
Decision Date2016-05-20
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2016-05-20 under approval number K160416. 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 CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2016-05-20. It is manufactured by Mauna Kea Technologies. The 510(k) number is K160416.

When was CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes approved by the FDA?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes received FDA 510(k) clearance on 2016-05-20, under approval number K160416.

What company makes CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes is manufactured by Mauna Kea Technologies.

What is the FDA product code for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes?

The FDA product code for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) 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

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 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. 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. K162885SPY Phi Open Field Handheld Fluorescence Imaging SystemNovadaq Technologies, 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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