# K013975: CP-Sleeve

- Pathway: 510(k) (Traditional)
- Applicant: Cp Medical
- Decided: Feb 22, 2002 after 81 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 K940632 (1994). 3 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K940632: I-125 Rapid Strand, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1994) Summary page 1.
- K010821: Echoseed/Iodine-125 Seeds, Model 6733, Medi-Physics Inc. Dba Nycomed Amersham Imaging (2001) Summary page 1.
- K010621: Accu-Space Absorbable Seeding Spacers, Cp Medical (2001) Summary page 1.

## Most influential descendants
- K034062: CP Sleeve and River Sleeve (2004), 5 descendants of its own
- 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
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 CP-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/K013975
Methodology: https://510kreport.com/methodology