# K073417: Embozene Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Celonova Biosciences, Inc.
- Decided: Dec 15, 2008 after 377 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: 6 generations back to K961923 (1996). 15 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033761: Gelspheres / Beadblock Compressible Microspheres, Biocompatibles UK Limited (2004) Summary page 1.
- K032707: Contour SE Microspheres (Syringe), Boston Scientific Corp (2003) Summary page 1.
- K034068: Contour SE Microspheres, Boston Scientific Corp (2004) Summary page 1.
- K071634: Modification to:Contour SE Microspheres, Boston Scientific Corp (2007) Summary page 1.

## Most influential descendants
- K132675: Embozene Microspheres (2013), 4 descendants of its own
- K133447: Embozene Color-Advanced Microspheres, Embozene Opaque (Non-Colored) Microspheres (2014), 2 descendants of its own
- K130307: Oncozene Microspheres 40UM, 2ML, Oncozene Microspheres 75UM, 2ML, Oncozene Microspheres 100UM, 2ML, Oncozene Microsphere (2013), 2 descendants of its own
- 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
EmbozeneTM Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.

Source page: https://510kreport.com/device/K073417
Methodology: https://510kreport.com/methodology