# K993280: Prostec 125I Brachytherapy Seeds

- Pathway: 510(k) (Traditional)
- Applicant: Prostec, LLC
- Decided: Mar 14, 2000 after 166 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
Longest line of descent: 1 generation back to K915156 (1992). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K915156: I-125 Seeds Code:  6702, Medi-Physics Inc. Dba Nycomed Amersham Imaging (1992) Summary page 1.

## Indications for use
1251 Brachytherapy Seeds are intended for permanent interstitial implantation in selected localized tumors. The devices are implanted as a source of nuclear radiation for therapy.

Source page: https://510kreport.com/device/K993280
Methodology: https://510kreport.com/methodology