# K974118: Worldwide Medical Technologies Seed Implant Needle Set

- Pathway: 510(k) (Traditional)
- Applicant: Worldwide Medical Technologies, LLC
- Decided: Jan 23, 1998 after 84 days
- Product code: IWJ (System, Applicator, Radionuclide, Manual)
- Device class: 1
- Regulation: 21 CFR 892.5650
- 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 intended use of the Worldwide Medical Technologies Seed Implant Needle is to introduce radionuclide seeds of I-125 or Pd-103 (purchased by the user directly from another manufacturer) into the body for radiation therapy. This device is typically used in the transperineal approach for radionuclide seed application in the prostate.

Source page: https://510kreport.com/device/K974118
Methodology: https://510kreport.com/methodology