Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K170018
StealthStationTM S8 ENT Software · Medtronic Navigation, Inc. · decided 2017-05-19 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| StealthStation Cranial Software | 9735762 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000234867 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075644 |
| (unnamed) | 9735742 | MEDTRONIC NAVIGATION, INC. | PGW | 00643169843929 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075309 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075101 |
| StealthStation | 9735762 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000063177 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075118 |
| StealthStation | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00643169858428 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075651 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | OLO PGW | 00763000075217 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075019 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075637 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075064 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000064730 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075668 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00643169931343 |
| StealthStation Cranial Software | 9735762 | MEDTRONIC NAVIGATION, INC. | HAW | 00763000125295 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000125066 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075071 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075088 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000116996 |
| StealthStation | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000125202 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000075095 |
| StealthStation | 9735920 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000238742 |
| StealthStation Cranial Software | 9735736 | MEDTRONIC NAVIGATION, INC. | PGW | 00763000238810 |