CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes— 510(k) K160416

Substantially Equivalent

Mauna Kea Technologies

FDA 510(k) clearance K160416 for CystoFlex UHD R-C, CelioFlex UHD 5-C, Cellvizio 100 Series (800) with Confocal Miniprobes, Substantially Equivalent on 2016-05-20. Applicant: Mauna Kea Technologies.

Clearance details

Applicant: Mauna Kea Technologies
Product code: Code OWN
Advisory panel: Gastroenterology, Urology
Date received: 2016-02-16
Decision date: 2016-05-20
Decision: Substantially Equivalent
Clearance type: Special
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.