Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Mauna Kea Technologies. It received FDA 510(k) clearance on 2020-02-28 under 510(k) 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. The listed applicant is Mauna Kea Technologies. The 510(k) number is K193416.

When did Cellvizio I.V.E. with Confocal Miniprobes receive FDA 510(k) clearance?

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

Who is the listed applicant for Cellvizio I.V.E. 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 I.V.E. with Confocal Miniprobes?

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

K220477Cellvizio 100 series system with confocal MiniprobesK212322Cellvizio I.V.E. system 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

View all 9 devices →

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.

↑