# K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Celonova Biosciences, Inc.
- Decided: Feb 24, 2014 after 104 days
- Product code: NAJ (Agents, Embolic, For Treatment Of Uterine Fibroids)
- 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: 8 generations back to K961923 (1996). 17 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 20 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 1.
- K132675: Embozene Microspheres, Celonova Biosciences, Inc. (2013) Summary page 1.
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization, Biosphere Medical, Inc. (2002) Summary page 1.
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter, Boston Scientific Corp (2003) Summary page 2.

## Most influential descendants
- K141209: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres, Oncozene Microspheres (2014), 1 descendant of its own
- K242794: ONCOZENE Microspheres (2024), 0 descendants of its own

## Indications for use
Ernbozene®I Microspheres are indicated for the embolization of arteriovenous mnalformations and hypervascular tumors, including uterine fibroids.

Source page: https://510kreport.com/device/K133447
Methodology: https://510kreport.com/methodology