# K142294: FlexiMarc Marker

- Pathway: 510(k) (Special)
- Applicant: Cortex Manufacturing, Inc.
- Decided: Mar 26, 2015 after 220 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 K100267 (2010). 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)
- K100267: Fleximarc, Model CM-0.9-2-10-GG-L, Cortex Manufacturing, Inc. (2010) Summary page 4.

## Indications for use
In situations where the location of specific anatomy, normal and diseased needs to be marked for future procedures this device will serve as a surrogate locator. The all gold FlexiMarc is placed either in advance or during a treatment procedure. These all gold FlexiMarcs can be visualized using medical imaging devices and they provide a reference from which the treatment can be guided.

Source page: https://510kreport.com/device/K142294
Methodology: https://510kreport.com/methodology