# K142344: DISPOSABLE PASSIVE ACCESSORY FOR MEDTRONIC StealthStation System

- Pathway: 510(k) (Traditional)
- Applicant: Izi Medical Products, LLC
- Decided: Mar 20, 2015 after 210 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 K022074 (2002). 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)
- K050438: Stealthstation System Update, Medtronic Surgical Navigation Technologies (2005) Summary page 5.
- K022074: Spherz, I.Z.I. Corp. (2002) Summary page 5.

## Most influential descendants
- K160523: BrightMatter Guide with BrightMatter Pointer (2016), 0 descendants of its own

## Indications for use
The Disposable Passive Accessory is intended to be used for anatomy palpation and registration in image guided surgeries with Medtronic StealthStation® System. The device is sterile and designed for single use.

Source page: https://510kreport.com/device/K142344
Methodology: https://510kreport.com/methodology