Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K193416
Cellvizio I.V.E. with Confocal Miniprobes · Mauna Kea Technologies · decided 2020-02-28 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| CholangioFlex™ N | FP-10035 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912073 |
| CystoFlex™ R N | FP-10032 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912042 |
| AlveoFlex™ N | FP-10029 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912011 |
| Cellvizio® I.V.E. | FP-10001 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912004 |
| CystoFlex™ F N | FP-10038 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912103 |
| Cellvizio® I.V.E. | FP-10001 | MAUNA KEA TECHNOLOGIES | OWN | 03760187913001 |
| GastroFlex™ N | FP-10030 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912028 |
| ColoFlex™ N | FP-10031 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912035 |
| CelioFlex™ 5 N | FP-10036 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912080 |
| UroFlex™ N | FP-10037 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912097 |
| AQ-Flex™ 19 N | FP-10033 | MAUNA KEA TECHNOLOGIES | OWN | 03760187912059 |