# K062214: Brachysciences Strandport

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Mar 1, 2007 after 212 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The World Wide Medical Technologies StrandPort intended use is to provide a disposable carrier for seed strands containing radionuclide seeds for the introduction by the user of radionuclide seeds into Prostate Seeding Needles for brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate. This device is a sterile, single patient use product.

Source page: https://510kreport.com/device/K062214
Methodology: https://510kreport.com/methodology