# K991344: Worldwide Medical Technologies Seeding Spacers

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Nov 5, 1999 after 200 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 Worldwide Medical Technologies Seeding Spacers intended use is to provide space between radionuclide seeds during the introduction of radionuclide seeds into the body for Brachytherapy procedures. The anatomical site is typically the transperineal approach for radionuclide seed application in and around the prostate.

Source page: https://510kreport.com/device/K991344
Methodology: https://510kreport.com/methodology
