# K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers

- Pathway: 510(k) (Special)
- Applicant: Cp Medical
- Decided: Jan 24, 2002 after 52 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 K010621 (2001). 1 ancestor in all.
25 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010621: Accu-Space Absorbable Seeding Spacers, Cp Medical (2001) Summary page 1.

## Most influential descendants
- K030594: I-125 Rapid Strand, Model 7000 (2003), 17 descendants of its own
- K040339: Brachytherapy Strand Device (2004), 14 descendants of its own
- K043596: Theraload Custom Loaded Needles, Models 200 and 125.S06 (2005), 9 descendants of its own
- K062384: Cesium-131 Strand, Strand Preload, Preload, S-Cartridge (2006), 7 descendants of its own
- K021311: Synthetic Absorbable Seeding Spacers Made of Polydioxanone Material (2002), 6 descendants of its own

## Indications for use
CP Medical's absorbable seeding spacers are intended to be used to maintain a predetermined space between radionuclide seeds for the introduction of the seeds into the body during brachytherapy procedures. Seeding spacers are 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/K013964
Methodology: https://510kreport.com/methodology