# K072296: Poiint of Care Stranding System, Mode 1004-00

- Pathway: 510(k) (Abbreviated)
- Applicant: Theragenics Corp.
- Decided: Sep 26, 2007 after 40 days
- Product code: KXK (Source, Brachytherapy, Radionuclide)
- Device class: 2
- Regulation: 21 CFR 892.5730
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K801748 (1980). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040339: Brachytherapy Strand Device, Bebig Isotopen-Und Medizintechnik GmbH (2004) Summary page 1.
- K013964: Modification to Accu-Space Plain Gut Absorbable Seeding Spacers, Cp Medical (2002) Summary page 1.
- K890341: Mick 200-TP and Mick TP Needle, Mick Radio-Nuclear Instruments, Inc. (1989) Summary page 1.
- K041576: Sourcelink, C.R. Bard, Inc. (2004) Summary page 1.

## Recalls of this device
- Dec 8, 2008 · Not classified · Z-1020-2009: Some pouches were found to have weak seals potentially compromising sterility.

## Indications for use
The Point of Care Stranding System provides a method for the physician to custom configure and assemble sterile TheraSeed® strands in the operating room at the time of the implant procedure. The Point of Care System may also be used to custom load sterile I-Seed in non-stranded configurations.

Source page: https://510kreport.com/device/K072296
Methodology: https://510kreport.com/methodology