# K010026: Embogold Microsphere

- Pathway: 510(k) (Special)
- Applicant: Biosphere Medical, Inc.
- Decided: Jun 21, 2001 after 169 days
- Product code: HCG (Device, Neurovascular Embolization)
- Device class: 2
- Regulation: 21 CFR 882.5950
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
59 later devices descend from it; 4 cite it directly.
1 of 60 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K021397: Embosphere Microspheres and Embogold Microspheres for Use in Uterine Fibroid Embolization (2002), 41 descendants of its own
- K023089: Gelspheres Embolic Agent (2002), 25 descendants of its own
- K033761: Gelspheres / Beadblock Compressible Microspheres (2004), 24 descendants of its own
- K030966: Contour Emboli Pva and Fastracker-325 Infusion Catheter (2003), 18 descendants of its own
- K042231: Gelspheres Microspheres and Bead Block Compressible Microspheres (2004), 17 descendants of its own

Source page: https://510kreport.com/device/K010026
Methodology: https://510kreport.com/methodology