# K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Celonova Biosciences, Inc.
- Decided: Aug 7, 2014 after 90 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: 9 generations back to K961923 (1996). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073417: Embozene Microspheres, Celonova Biosciences, Inc. (2008) Summary page 5.
- K132675: Embozene Microspheres, Celonova Biosciences, Inc. (2013) Summary page 5.
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Celonova Biosciences, Inc. (2014) Summary page 5.
- K130307: Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere, Celonova Biosciences, Inc. (2013) Summary page 5.

## Most influential descendants
- K242794: ONCOZENE Microspheres (2024), 0 descendants of its own

## Indications for use
Embozene® Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including uterine fibroids and hepatoma. ONCOZENE™ Microspheres are indicated for the embolization of arteriovenous malformations and hypervascular tumors including hepatoma.

Source page: https://510kreport.com/device/K141209
Methodology: https://510kreport.com/methodology