# K042231: Gelspheres Microspheres and Bead Block Compressible Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles UK Limited
- Decided: Nov 12, 2004 after 87 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: 3 generations back to K010026 (2001). 3 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023089: Gelspheres Embolic Agent, Biocure, Inc. (2002) Summary page 1.
- K033761: Gelspheres / Beadblock Compressible Microspheres, Biocompatibles UK Limited (2004) Summary page 1.

## Most influential descendants
- K052742: Hepasphere Microspheres (2006), 11 descendants of its own
- K113266: Gel-Block Embolization Pledgets (2012), 8 descendants of its own
- K083091: LC Bead Microspheres, Bead Block Compressible Microspheres (2008), 4 descendants of its own
- K143038: Gel-Block 10X embolization pledgets (2014), 2 descendants of its own
- K133237: Gel-Bead Embolization Spheres (2014), 2 descendants of its own

## Indications for use
"GelSpheresTM Microspheres & Bead BlockTM Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations."

Source page: https://510kreport.com/device/K042231
Methodology: https://510kreport.com/methodology