# K091645: Gold Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Naslund Medical AB
- Decided: Jul 21, 2009 after 47 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: 6 generations back to K874787 (1987). 11 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070305: Pre-Loaded Visicoil, Radiomed Corporation (2007) Summary page 1.

## Most influential descendants
- K160209: Gold Anchor (2016), 2 descendants of its own
- K201117: Gold Anchor (2020), 1 descendant of its own
- K213053: Gold Anchor (2022), 0 descendants of its own

## Indications for use
Gold Anchor is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K091645
Methodology: https://510kreport.com/methodology