# K023089: Gelspheres Embolic Agent

- Pathway: 510(k) (Traditional)
- Applicant: Biocure, Inc.
- Decided: Dec 16, 2002 after 90 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
Longest line of descent: 1 generation back to K010026 (2001). 1 ancestor in all.
25 later devices descend from it; 3 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010026: Embogold Microsphere, Biosphere Medical, Inc. (2001)

## Cited in the summary but kept off the family tree
- K891549: Embospheres Microspheres. Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K033761: Gelspheres / Beadblock Compressible Microspheres (2004), 24 descendants of its own
- K042231: Gelspheres Microspheres and Bead Block Compressible Microspheres (2004), 17 descendants of its own
- K052742: Hepasphere Microspheres (2006), 11 descendants of its own
- K113266: Gel-Block Embolization Pledgets (2012), 8 descendants of its own
- K073417: Embozene Microspheres (2008), 6 descendants of its own

## Indications for use
GelSpheresm Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations.

Source page: https://510kreport.com/device/K023089
Methodology: https://510kreport.com/methodology