# K162604: Cranial Reducing Tubes

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Navigation, Inc.
- Decided: Dec 30, 2016 after 102 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: 1 generation back to K992304 (1999). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992304: Navigus Trajectory Guide, Model TG-XXXX, Image-Guided Neurologics, Inc. (1999) Summary page 4.
- K012366: Navigus II Trajectory Guide, Image-Guided Neurologics, Inc. (2001) Summary page 4.

## Most influential descendants
- K253663: Zeta Navigation System (2026), 0 descendants of its own

## Indications for use
The Cranial Reducing Tubes are intended to maintain the position of instruments or devices placed using stereotactic guidance during planning and operation of neurological procedures performed in conjunction with the use of the Medtronic StealthStation System Image Guided Workstation. The devices were not tested for MR compatibility, and are not intended for use in an MRI environment.

Source page: https://510kreport.com/device/K162604
Methodology: https://510kreport.com/methodology