CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES— 510(k) K141358
Substantially EquivalentMauna Kea Technologies
FDA 510(k) clearance K141358 for CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES, Substantially Equivalent on 2014-09-25. 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
- Gardnerville, NV, 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.