# K120859: Pre-Loaded Gold Visicoil CK Marker

- Pathway: 510(k) (Special)
- Applicant: Radiomed Corporation
- Decided: Apr 19, 2012 after 28 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- 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). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 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.
- K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers, Riverpoint Medical (2011) Summary page 2.

## Indications for use
Pre-Loaded CK Visicoil Gold Marker is indicated for use to radiographically mark soft tissue for future therapeutic procedures.

Source page: https://510kreport.com/device/K120859
Methodology: https://510kreport.com/methodology