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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 the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2022-04-11 under 510(k) 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. The listed applicant is Mauna Kea Technologies. The 510(k) number is K220477.

When did Cellvizio 100 series system with confocal Miniprobes receive FDA 510(k) clearance?

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

Who is the listed applicant for Cellvizio 100 series system with confocal Miniprobes?

The FDA 510(k) record lists Mauna Kea Technologies as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Mauna Kea Technologies as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K212322Cellvizio I.V.E. system with Confocal MiniprobesK193416Cellvizio I.V.E. with Confocal MiniprobesK191144Cellvizio 100 Series System with Confocal MiniprobesK183640Cellvizio 100 Series Confocal laser Imaging systems and their Confocal MiniprobesK180270Cellvizio 100 Series Systems with Confocal MiniprobesK172844Cellvizio 100 Series System with Confocal Miniprobes

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Related Devices (Code: OWN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254180PerfusiX-ImagingLIMIS Development B.V.K242163SmartSurgN Visualization SystemSmartsurgN, Inc.K254242KARL STORZ ICG Imaging System with RUBINA® LensKarl Storz SE & CO. KGK251852cCeLL - In vivo with Drop-In Robo (CN100-2W2C488775, CN100-1W1C775, DR200)VPIX Medical, Inc.K260108L12 LED Light Source with AIMStryker EndoscopyK253972IMAGE1 (TC400US); X-to-4U Adapter (TC040)Karl Storz SE & CO. KG

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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