# K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization

- Pathway: 510(k) (Traditional)
- Applicant: Biosphere Medical, Inc.
- Decided: Nov 22, 2002 after 204 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: 3 generations back to K961923 (1996). 6 ancestors in all.
41 later devices descend from it; 10 cite it directly.
1 of 48 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991549: Embosphere Microspheres, Biosphere Medical (2000) Summary page 1.
- K010026: Embogold Microsphere, Biosphere Medical, Inc. (2001)

## Most influential descendants
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter (2003), 18 descendants of its own
- K034068: Contour SE Microspheres (2004), 10 descendants of its own
- K181300: Embosphere Microspheres (2018), 9 descendants of its own
- K183120: EmboCube Embolization Gelatin (2019), 7 descendants of its own
- K073417: Embozene Microspheres (2008), 6 descendants of its own

## Indications for use
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.

Source page: https://510kreport.com/device/K021397
Methodology: https://510kreport.com/methodology