# K173891: Gel-Bead (600-800 micron) - 1 ml sphere volume, Gel-Bead (600-800 micron) - 2 ml sphere volume

- Pathway: 510(k) (Special)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 19, 2018 after 29 days
- Product code: KRD (Device, Vascular, For Promoting Embolization)
- 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: 8 generations back to K010026 (2001). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133237: Gel-Bead Embolization Spheres, Vascular Solutions, Inc. (2014) Summary page 4.
- K171946: Gel-Bead, Vascular Solutions, Inc. (2017) Summary page 4.

## Indications for use
Gel-Bead embolization spheres are intended for use in embolization of hypervascular tumors.

Source page: https://510kreport.com/device/K173891
Methodology: https://510kreport.com/methodology