Navigus Trajectory Guide Biopsy Kit, Models Bk-7000 and 8000
by Image-Guided Neurologics, Inc.
510(k) K011971
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK011971 | Date3 Aug 2001 | 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- Withdrawn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 Navigus Trajectory Guide Biopsy Kit, Models BK-7000 and BK-8000, is a stereotactic instrument designed for brain biopsy procedures. It provides precise guidance for needle placement, integrating with a Frameless Image-Guided Workstation system or CT imaging to enhance accuracy during interventions. This device is classified under neurological stereotaxic instruments and is intended for use in neurosurgical settings where targeted tissue sampling is required. Its construction supports controlled, repeatable trajectories to minimize procedural risks.
The kit is supplied as a single-use device, intended for one-time clinical application. It is regulated under FDA 510(k) clearance (K011971) and falls under the product code HAW, classified as a neurological stereotaxic instrument. No additional sterility or MRI safety specifications are noted in the available data. Storage and handling must comply with standard single-use medical device protocols to ensure integrity before use. The device’s design aligns with FDA-substantiated equivalence to prior-generation technologies in the field of neurosurgical guidance.
Other devices from Image-Guided Neurologics, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Navigus BK-7000/8000 Biopsy Kit used for?
The Navigus BK-7000 and BK-8000 Biopsy Kits are designed specifically for brain biopsy procedures in neurosurgical settings. They provide precise stereotactic guidance for needle placement, integrating with a Frameless Image-Guided Workstation or CT imaging to enhance accuracy. This ensures controlled, repeatable trajectories, which helps minimize procedural risks during targeted tissue sampling.
Are the BK-7000 and BK-8000 models single-use or reusable?
Both the BK-7000 and BK-8000 models are supplied as single-use devices. This design ensures sterility and safety for one-time clinical application, adhering to standard protocols for single-use medical devices. Reuse is not recommended or supported by the manufacturer.
What regulatory clearance does the Navigus Biopsy Kit hold?
The Navigus Trajectory Guide Biopsy Kit, Models BK-7000 and BK-8000, holds FDA 510(k) clearance under the reference number K011971. This clearance is based on a substantial equivalence determination to prior-generation technologies in the field of neurosurgical guidance, as reviewed by the FDA’s Neurology Advisory Committee.
How should the BK-7000/8000 Biopsy Kit be stored?
The kit must be stored according to standard single-use medical device protocols to maintain its integrity before use. Specific storage instructions are not detailed in the available data, but it is critical to follow manufacturer guidelines to prevent contamination or damage. Ensure the packaging remains unopened and sealed until ready for clinical application.
Does the BK-7000/8000 Biopsy Kit have any special sterility or MRI safety requirements?
The available data does not specify any additional sterility requirements beyond those expected for a single-use medical device. Similarly, there are no noted MRI safety specifications for this kit. Always verify compatibility with your facility’s imaging systems and protocols before use.