# K140705: Navigable Brain Biopsy Cannula Set

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical Products
- Decided: Dec 5, 2014 after 259 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K983831 (1999). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012564: Modification to: Vectorvision Frameless Biopsy System, Brainlab AG (2001) Summary page 4.
- K971247: SNT Disposable Biopsy Needle, Surgical Navigation Technologies, Inc. (1997) Summary page 4.

## Indications for use
The BL Navigated Biopsy Needle is indicated for stereotactic biopsy of cranial tissue using BrainLab AG’s VectorVision navigation system. The Navigated Biopsy Needle is a pre-sterilized, single-use, side-cutting needle where the cutting action is achieved by rotation of an inner cannula within an outer cannula.

Source page: https://510kreport.com/device/K140705
Methodology: https://510kreport.com/methodology