NavSuite3 Kit
by Stryker Leibinger GmbH & Co. KG - Navigation
510(k) K150301
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK150301 | Date8 Jul 2015 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The NavSuite3 Kit is a Neurological Stereotaxic Instrument (product code HAW), designed for precise navigation and guidance in neurosurgical procedures. It integrates advanced imaging and tracking technologies to assist in the accurate placement of instruments, implants, or interventions within the brain. This system supports real-time visualization and alignment, enhancing procedural precision and reducing potential risks associated with off-target placement. Its classification as a Class II device under Special Controls underscores its role in high-precision, minimally invasive neurosurgical applications.
The NavSuite3 Kit is supplied as a reusable system intended for use in sterile operating room environments, where it interfaces with MRI-compatible or non-MRI equipment depending on clinical requirements. It is intended for single-user sessions and requires proper calibration and maintenance as outlined in the manufacturer’s instructions. The device’s regulatory clearance (FDA 510K, K150301) reflects its compliance with U.S. standards for neurological navigation instruments, ensuring adherence to safety and performance criteria for neurosurgical navigation. Storage and handling follow standard sterile medical device protocols to preserve functionality and sterility.
Questions
AI-generated answers, 1 Oct 2026
What is the NavSuite3 Kit used for in neurosurgery?
The NavSuite3 Kit is designed for precise navigation and guidance during neurosurgical procedures. It integrates advanced imaging and tracking technologies to assist in the accurate placement of instruments, implants, or interventions within the brain. This helps reduce risks associated with off-target placement by providing real-time visualization and alignment, making it ideal for minimally invasive neurosurgery.
Is the NavSuite3 Kit reusable or single-use?
The NavSuite3 Kit is supplied as a reusable system. It is intended for single-user sessions in sterile operating room environments, where it interfaces with MRI-compatible or non-MRI equipment based on clinical needs. Proper calibration and maintenance, as outlined in the manufacturer’s instructions, are required to ensure optimal performance and sterility.
How should the NavSuite3 Kit be stored and handled?
The NavSuite3 Kit must be stored and handled following standard sterile medical device protocols to maintain functionality and sterility. Since it is reusable, it should be cleaned, calibrated, and maintained according to the manufacturer’s guidelines after each use to ensure compliance with safety and performance standards for neurosurgical navigation.
Can the NavSuite3 Kit be used with MRI equipment?
Yes, the NavSuite3 Kit is designed to interface with both MRI-compatible and non-MRI equipment, depending on the clinical requirements of the procedure. This flexibility allows it to be used in a variety of operating room settings, ensuring compatibility with existing imaging infrastructure.
What regulatory clearance does the NavSuite3 Kit hold?
The NavSuite3 Kit holds FDA 510K clearance (K150301), which confirms its substantial equivalence to a predicate device under U.S. standards. This clearance ensures the device meets safety and performance criteria for neurological navigation instruments, specifically classified as a Class II device under Special Controls for high-precision neurosurgical applications.