CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES— 510(k) K123676
Substantially EquivalentMauna Kea Technologies
FDA 510(k) clearance K123676 for CELLVIZIO 100 SERIES AND CELLVIZIO SYSTEMS WITH CONFOCAL MINIPROBES, Substantially Equivalent on 2013-04-18. Applicant: Mauna Kea Technologies. Device class: 2.
Clearance details
- Applicant
- Mauna Kea Technologies
- Product code
- Code OWN
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Orinda, CA, US
Recent devices under product code OWN
view allMore clearances from Mauna Kea Technologies
view all- K220477 — Cellvizio 100 series system with confocal Miniprobes
- K212322 — Cellvizio I.V.E. system with Confocal Miniprobes
- K193416 — Cellvizio I.V.E. with Confocal Miniprobes
- K191144 — Cellvizio 100 Series System with Confocal Miniprobes
- K183640 — Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
Adverse events under product code OWN
product code OWN- Malfunction
- 1,286
- Total
- 1,286
Source: openFDA MAUDE database, through . 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.