StealthStation S8 Cranial v2.0
FDA 510(k) clearance K212397 · decided 2021-12-22
Clearance details
- K-number
- K212397
- Device name
- StealthStation S8 Cranial v2.0
- Applicant
- Medtronic Navigation
- Decision
- Substantially Equivalent
- Date received
- 2021-08-02
- Decision date
- 2021-12-22
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- HAW
- Device class
- 2
- Regulation number
- 882.4560
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Louisville, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation Syst recall (Z-0188-2024) | Medtronic Navigation, Inc. | 2023-11-10 |