# K213053: Gold Anchor

- Pathway: 510(k) (Traditional)
- Applicant: Naslund Medical AB
- Decided: Jan 6, 2022 after 106 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: 9 generations back to K874787 (1987). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201117: Gold Anchor, Naslund Medical AB (2020) Summary page 4.

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

Source page: https://510kreport.com/device/K213053
Methodology: https://510kreport.com/methodology