← Back to catalogue
StealthStation S8 System Platforms and StealthStation Cranial Software
FDA 510(k)Class II (US FDA 510(k))
510(k) K162309
Identifiers
- 510(k) Number
- K162309 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
StealthStation S8 System Platforms and StealthStation Cranial Software by Medtronic Navigation, Inc. — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K162309 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medtronic Navigation, Inc.
Sources (1)
- FDA 510(k) K162309 24 fields · synced Jun 19, 2026