StealthStation S8 System Platforms and StealthStation Cranial Software
FDA 510(k) K162309 · Medtronic Navigation, Inc.
510(k) numberK162309
Submission
- Device name
- StealthStation S8 System Platforms and StealthStation Cranial Software
- Applicant
- Medtronic Navigation, Inc.
Louisville, CO, US - Received
- August 17, 2016
- Decision date
- March 31, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code HAW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253856 | Geniant Cranial (Navigated Neurosurgical Positioning Robot)HAW · Traditional | Koh Young Technology, Inc. | 09/10/2026SE |
| K261932 | Leksell® Vantage Stereotactic SystemHAW · Traditional | Elekta Solutions AB | 08/05/2026SE |
| K253663 | Zeta Navigation SystemHAW · Traditional | Zeta Surgical, Inc. | 05/01/2026SE |
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | Medtronic Navigation, Inc. | 03/26/2026SE |
| K231897 | NeuroAlign softwareHAW · Traditional | Medivis, Inc. | 10/21/2025SE |
| K251317 | SOLOPASS 2.0 SystemHAW · Traditional | Intravent Medical Partners | 09/05/2025SE |
| K250893 | Ball Joint Guide Array (66295)HAW · Traditional | Bayer Medical Care, Inc. | 09/04/2025SE |
| K250505 | Ez-FiducialsHAW · Traditional | Phasor Health, LLC | 07/09/2025SE |
| K242575 | Stereotaxic Guiding Surgical Devices, NaoTrac SHAW · Traditional | Brain Navi Biotechnology Co., Ltd. | 05/23/2025SE |
| K241327 | Navient Image Guide Navigation System (955-NC-NC), CranialHAW · Traditional | Claronav | 02/05/2025SE |
More from Claronav
| 510(k) | Device | Decision |
|---|---|---|
| K253379 | Stealth AXiS Cranial clinical applicationHAW · Traditional | 03/26/2026SE |
| K253395 | Stealth AXiS ENT clinical applicationPGW · Traditional | 03/16/2026SE |
| K253391 | Visualase Cooled Laser Applicator System (9735559); Visualase Cooled Laser Applicator…ONO · Traditional | 03/13/2026SE |
| K253381 | Stealth AXiS Surgical System with Stealth AXiS Spine clinical applicationOLO · Traditional | 02/12/2026SE |
| K251282 | StealthStation S8 Spine SoftwareOLO · Traditional | 10/17/2025SE |
| K242464 | Stealth Spine Clamps; ModuLeX Shank MountsOLO · Traditional | 06/05/2025SE |
| K250307 | Visualase V2 MRI-guided Laser Ablation System (9736422)ONO · Traditional | 05/29/2025SE |
| K240465 | O-arm O2 Imaging SystemOWB · Traditional | 06/21/2024SE |
| K231976 | StealthStation Cranial Software, v3.1.5 (9735585)HAW · Traditional | 10/19/2023SE |
| K221087 | Synergy Cranial v2.2.9, StealthStation Cranial v3.1.4HAW · Traditional | 06/10/2022SE |
Questions and answers
When was StealthStation S8 System Platforms and StealthStation Cranial Software cleared by the FDA?
StealthStation S8 System Platforms and StealthStation Cranial Software (K162309) received a 510(k) decision of Substantially Equivalent on March 31, 2017, 226 days after the submission was received.
What is the product code of K162309?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.