Stealthstation System
FDA 510(k) K963173 · Surgical Navigation Technologies, Inc.
510(k) numberK963173
Submission
- Device name
- Stealthstation System
- Applicant
- Surgical Navigation Technologies, Inc.
Broomfield, CO, US - Received
- August 14, 1996
- Decision date
- October 25, 1996
- 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 |
|---|---|---|
| K000246 | Radiocameras Extracranial SystemIYE · Traditional | 10/20/2000SE |
| K994355 | Radiocameras System Head/Neck ApplicationIYE · Traditional | 03/22/2000SE |
| K992461 | Stealthstation Treatment Guidance PlatformHAW · Traditional | 02/22/2000SE |
| K992927 | Stealthstation Treatment Guidance PlatformHAW · Traditional | 12/29/1999SE |
| K993021 | Metrx SystemHRX · Traditional | 11/10/1999SE |
| K992354 | SNT Image Analysis SystemLLZ · Traditional | 10/12/1999SE |
| K991468 | Immerge Image CorrelationLLZ · Traditional | 07/06/1999SE |
| K990214 | Fluoronav Module for the Stealthstation SystemHAW · Traditional | 04/22/1999SE |
| K983670 | Stealthstation SystemHAW · Traditional | 01/14/1999SE |
| K984000 | Stealthserver Image Storage and Communication SystemLMD · Traditional | 01/12/1999SE |
Questions and answers
When was Stealthstation System cleared by the FDA?
Stealthstation System (K963173) received a 510(k) decision of Substantially Equivalent on October 25, 1996, 72 days after the submission was received.
What is the product code of K963173?
The FDA product code is HAW – Neurological Stereotaxic Instrument, a Class II (moderate risk) device regulated under 21 CFR 882.4560.