CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX— 510(k) K061666

Substantially Equivalent

Mauna Kea Technologies

FDA 510(k) clearance K061666 for CELLVIZIO WITH CONFOCAL MINIPROBES, MODEL F-600; COLOFLEX AND GASTROFLEX, Substantially Equivalent on 2006-08-24. Applicant: Mauna Kea Technologies.

Clearance details

Applicant: Mauna Kea Technologies
Product code: Code GCJ
Advisory panel: Gastroenterology, Urology
Date received: 2006-06-14
Decision date: 2006-08-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Paris, FR

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Adverse events under product code GCJ

product code GCJ

Death: 39
Injury: 1,638
Malfunction: 28,216
Other: 11
Total: 29,904

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.