Stealthstation System Update
FDA 510(k) K050438 · Medtronic Surgical Navigation Technologies
510(k) numberK050438
Submission
- Device name
- Stealthstation System Update
- Applicant
- Medtronic Surgical Navigation Technologies
Louisville, CO, US - Received
- February 22, 2005
- Decision date
- June 2, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K043088 | Medtronic SNT Stealthstation Axiem Imageless Knee ModuleHAW · Traditional | 01/05/2005SE |
| K030552 | Imageless Knee Module for the Stealthstation SystemHAW · Special | 03/19/2003SE |
| K030106 | Stealthstation System Advanced Contour Registration Software ModuleHAW · Special | 02/12/2003SE |
| K022126 | Catheter Introducer for the Stealthstation SystemHAW · Traditional | 01/03/2003SE |
| K021980 | Hip Module for the Stealthstation SystemHAW · Traditional | 11/19/2002SE |
| K022414 | Stealthstation System Three Dimensional C-Arm InterfaceHAW · Special | 08/14/2002SE |
| K020338 | Stealthstation with Fluoromerge SoftwareHAW · Special | 02/27/2002SE |
| K012937 | Knee Module for the Stealthstation SystemHAW · Traditional | 01/25/2002SE |
| K002869 | Localisa Cardiac Navigation SystemDQK · Traditional | 03/27/2001SE |
| K003201 | Stealthstation Treatment Guidance PlatformHAW · Traditional | 12/12/2000SE |
Questions and answers
When was Stealthstation System Update cleared by the FDA?
Stealthstation System Update (K050438) received a 510(k) decision of Substantially Equivalent on June 2, 2005, 100 days after the submission was received.
What is the product code of K050438?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.