# K103449: Brachytherapy Needles, RP Sleeve, RP Brachy-Spacer, Gold Makers

- Pathway: 510(k) (Abbreviated)
- Applicant: Riverpoint Medical
- Decided: Feb 25, 2011 after 94 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: 4 generations back to K010621 (2001). 10 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071550: Pre-Waxed Needles with Gold Fiduciary Markers, Cp Medical (2007) Summary page 2.
- K034062: CP Sleeve and River Sleeve, Cp Medical (2004) Summary page 2.
- K010621: Accu-Space Absorbable Seeding Spacers, Cp Medical (2001) Summary page 2.
- K100267: Fleximarc, Model CM-0.9-2-10-GG-L, Cortex Manufacturing, Inc. (2010) Summary page 2.

## Most influential descendants
- 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
RP Brachytherapy Needles are intended to be used for the placement of radionuclide seeds, and/or gold markers and/or Brachytherapy spacer/sleeve accessories during Brachytherapy or IMRT procedures. The RP Sleeve is intended to be used to facilitate the placement and containment of radioactive seeds and gold markers with or without spacers into the body during Brachytherapy or IMRT procedures. The RP Spacer is intended to be used during Brachytherapy or IMRT procedures to facilitate the implant of radionuclide seeds or gold markers at predetermined intervals within the body tissue. Spacers are indicated for use in soft tissues or organ tissue, but not to be used during cardiovascular or neurological procedures. RP Gold Markers are intended to provide localization information during Brachytherapy, IMRT, or other procedures involving radiation treatments.

Source page: https://510kreport.com/device/K103449
Methodology: https://510kreport.com/methodology