Cellvizio 100 Series System with Confocal Miniprobes— 510(k) K151593

Substantially Equivalent

Mauna Kea Technologies

FDA 510(k) clearance K151593 for Cellvizio 100 Series System with Confocal Miniprobes, Substantially Equivalent on 2015-10-23. Applicant: Mauna Kea Technologies.

Clearance details

Applicant: Mauna Kea Technologies
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2015-06-12
Decision date: 2015-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code OWN

product code OWN

Malfunction: 1,286
Total: 1,286

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.