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FDA 510(k)

Cellvizio 100 series system with confocal Miniprobes

K-Number: K220477 · 2022-04-11

ApplicantMauna Kea Technologies
Decision Date2022-04-11
Product CodeOWN
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Cellvizio 100 series system with confocal Miniprobes is a medical device manufactured by Mauna Kea Technologies. It received FDA 510(k) clearance on 2022-04-11 under approval number K220477. 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 100 series system with confocal Miniprobes?

Cellvizio 100 series system with confocal Miniprobes is a medical device that received FDA 510(k) clearance on 2022-04-11. It is manufactured by Mauna Kea Technologies. The 510(k) number is K220477.

When was Cellvizio 100 series system with confocal Miniprobes approved by the FDA?

Cellvizio 100 series system with confocal Miniprobes received FDA 510(k) clearance on 2022-04-11, under approval number K220477.

What company makes Cellvizio 100 series system with confocal Miniprobes?

Cellvizio 100 series system with confocal Miniprobes is manufactured by Mauna Kea Technologies.

What is the FDA product code for Cellvizio 100 series system with confocal Miniprobes?

The FDA product code for Cellvizio 100 series system with confocal Miniprobes is OWN.

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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

View all 9 devices →

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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