# K092041: Stellar Fiducial Marker, Model Gfmia

- Pathway: 510(k) (Traditional)
- Applicant: Stellar Medical, LLC
- Decided: Oct 2, 2009 after 87 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- 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 K071614 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071614: Fiducial Markers, Civco (2007) Summary page 1.

## Indications for use
The needles are used for interstitial placement of gold fiducial markers. Once implanted, the gold fiducial markers are used as localization targets for the process in IMRT, and IGRT radiation therapy.

Source page: https://510kreport.com/device/K092041
Methodology: https://510kreport.com/methodology