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FDA 510(k)

CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX

K-Number: K061666 · 2006-08-24

ApplicantMauna Kea Technologies
Decision Date2006-08-24
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX 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 2006-08-24 under 510(k) number K061666. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX?

CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX is a medical device that received FDA 510(k) clearance on 2006-08-24. The listed applicant is Mauna Kea Technologies. The 510(k) number is K061666.

When did CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX receive FDA 510(k) clearance?

CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX received FDA 510(k) clearance on 2006-08-24, under 510(k) number K061666.

Who is the listed applicant for CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX?

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 WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX?

The FDA product code for CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX is GCJ.

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Related Devices (Code: GCJ)

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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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