# K033761: Gelspheres / Beadblock Compressible Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles UK Limited
- Decided: Feb 4, 2004 after 64 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: 2 generations back to K010026 (2001). 2 ancestors in all.
24 later devices descend from it; 4 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)
- K023089: Gelspheres Embolic Agent, Biocure, Inc. (2002) Summary page 3.

## Most influential descendants
- 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
- K132675: Embozene Microspheres (2013), 4 descendants of its own

## Indications for use
GelSpheresTM Compressible Microsphere and BeadBlockTM Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

Source page: https://510kreport.com/device/K033761
Methodology: https://510kreport.com/methodology