# K034062: CP Sleeve and River Sleeve

- Pathway: 510(k) (Special)
- Applicant: Cp Medical
- Decided: Jan 30, 2004 after 30 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: 3 generations back to K010621 (2001). 6 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013975: CP-Sleeve, Cp Medical (2002) Summary page 1.
- K021311: Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material, Cp Medical (2002) 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
- K061638: Best Strand and Best Spacer (2006), 0 descendants of its own

## Indications for use
CP Medical's synthetic, absorbable placement sleeve accessory is intended to be used with absorbable seeding spacers to facilitate the introduction of radionuclide seeds and spacers into the body during Brachytherapy procedures. It is used to orient, hold, carry and maintain spacing of the radionuclide seeds and the spacer component. The Carrier Sleeve is indicated for use in soft tissues or organ tissue but should not be used during cardiovascular or neurological procedures.

Source page: https://510kreport.com/device/K034062
Methodology: https://510kreport.com/methodology