Identifiers
- 510(k) Number
- K974187 FDA 510(k)
- FDA Product Code
- HAW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.4560 FDA 510(k)
- Regulation Number
- 882.4560 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The StealthStation System is a surgical navigation device designed to assist in the precise localization of anatomical structures during open or percutaneous procedures. It integrates hardware, software, tracking algorithms, and image data merging to provide real-time visualization and guidance for cranial and spinal surgeries. This system enhances surgical accuracy by enabling the tracking of instruments throughout a procedure, supporting complex interventions where spatial orientation is critical.
The device is supplied as a reusable system and is intended for use in operating room environments. It requires no specific sterility classification beyond standard surgical instrument protocols, though its components must be cleaned and maintained according to manufacturer guidelines. The system is FDA-cleared under 510(k) number K974187, with a traditional review pathway through the Neurology advisory committee. No MRI safety classification or single-use designation is specified in the regulatory data.
Frequently asked questions
What is the StealthStation System used for?
The StealthStation System is used to assist in the precise localization of anatomical structures during open or percutaneous procedures, particularly in cranial and spinal surgeries.
Is the StealthStation System reusable?
Yes, the StealthStation System is supplied as a reusable system, requiring cleaning and maintenance according to manufacturer guidelines.
What regulatory pathway did the StealthStation System follow?
The StealthStation System was cleared through the traditional 510(k) review pathway by the FDA, with review by the Neurology advisory committee.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: StealthStation™ S8 navigation platform - Medtronic, StealthStation™ S8 planning station - Medtronic, STEALTHSTATION SYSTEM by SURGICAL NAVIGATION TECHNOLOGIES, INC. | FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K974187 | Class II | Active |
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Manufacturer
- Manufacturer
- Surgical Navigation Technologies, Inc.
Sources (1)
- FDA 510(k) K974187 24 fields · synced Oct 1, 2026