# K973184: Prostate Seeding Needle

- Pathway: 510(k) (Traditional)
- Applicant: Promex, Inc.
- Decided: Nov 21, 1997 after 88 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K052435: Pneumrx Family of Biopsy Needles and Kits (2005), 0 descendants of its own

## Indications for use
For the manual application of a radionuclide source into the body for radiation therapy.

Source page: https://510kreport.com/device/K973184
Methodology: https://510kreport.com/methodology