StealthStation System with Cranial Software
FDA 510(k) clearance K153660 · decided 2016-09-14
Clearance details
- K-number
- K153660
- Device name
- StealthStation System with Cranial Software
- Applicant
- Medtronic Navigation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-12-21
- Decision date
- 2016-09-14
- Days to decision
- 268 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 Cranial Software, Model: 9735585, used with StealthStation S7/i7 systems recall (Z-1666-2023) | Medtronic Navigation, Inc. | 2023-06-02 |
| Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or recall (Z-1995-2020) | Medtronic Navigation, Inc. | 2020-05-18 |
| StealthStation Cranial and Synergy Cranial Depth Gauge: StealthStation Cranial Optical Poc recall (Z-0552-2019) | Medtronic Navigation, Inc. | 2018-12-29 |