StealthStation S8 System Platforms and StealthStation Cranial Software
FDA 510(k) clearance K162309 · decided 2017-03-31
Clearance details
- K-number
- K162309
- Device name
- StealthStation S8 System Platforms and StealthStation Cranial Software
- Applicant
- Medtronic Navigation, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-08-17
- Decision date
- 2017-03-31
- Days to decision
- 226 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
+ Add to Predicate Builder ◉ Watch Medtronic Navigation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stealth S8 Clinical Software Application, REF: 9735762, CE0344, Rx Only. Used in the Steal recall (Z-1776-2024) | Medtronic Navigation, Inc. | 2024-05-09 |
| Medtronic Nexframe Stereotactic System and StealthStation Cranial software version 3.0 or recall (Z-1995-2020) | Medtronic Navigation, Inc. | 2020-05-18 |