# K242794: ONCOZENE Microspheres

- Pathway: 510(k) (Special)
- Applicant: Varian Medical Systems, Inc.
- Decided: Oct 16, 2024 after 30 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- Device class: 2
- Regulation: 21 CFR 870.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K961923 (1996). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres, Celonova Biosciences, Inc. (2014) Summary page 5.

## Indications for use
ONCOZENE Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

Source page: https://510kreport.com/device/K242794
Methodology: https://510kreport.com/methodology