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

FDA 510(k)

Cellvizio 100 Series System with Confocal Miniprobes

K-Number: K191144 · 2020-01-24

ApplicantMauna Kea Technologies
Decision Date2020-01-24
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 2020-01-24 under approval number K191144. 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 2020-01-24. It is manufactured by Mauna Kea Technologies. The 510(k) number is K191144.

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 2020-01-24, under approval number K191144.

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.

Related Clinical Trials

NCT06642935 A Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss ACTIVE_NOT_RECRUITING NCT07194265 A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System RECRUITING NCT07571239 Altius Peripheral Nerve Stimulation in Amputees After TMR/RPNI NOT_YET_RECRUITING NCT06220565 Evaluation of Product Effectiveness of the Intervention for Patients With Knee Osteoarthritis COMPLETED NCT07139327 A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults ACTIVE_NOT_RECRUITING NCT06507579 Hydra Registry - UK RECRUITING

Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025)

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.

↑