# K071550: Pre-Waxed Needles with Gold Fiduciary Markers

- Pathway: 510(k) (Abbreviated)
- Applicant: Cp Medical
- Decided: Jul 18, 2007 after 42 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: 1 generation back to K043117 (2004). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043117: Best Radiopaque Strand; Best Radiopaque Marker, Best Medical International, Inc. (2004) Summary page 1.

## Most influential descendants
- K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers (2011), 3 descendants of its own
- K131689: Mri Marker (2013), 1 descendant of its own
- K171487: Sirius MRI Marker NS (2017), 0 descendants of its own
- K120859: Pre-Loaded Gold Visicoil CK Marker (2012), 0 descendants of its own

## Indications for use
The needles are used for interstitial placement of gold seed markers. Once implanted, the gold markers serve as localization devices for the purpose of radiation therapy.

Source page: https://510kreport.com/device/K071550
Methodology: https://510kreport.com/methodology