# K180102: Embozene Color-Advanced Microspheres

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific
- Decided: Apr 19, 2018 after 93 days
- Product code: NOY (Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia)
- Device class: 2
- Regulation: 21 CFR 876.5550
- 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 DEN160040 (2017). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN160040: Embosphere Microspheres, Biosphere Medical, S.A. (2017) Summary page 4.

## Most influential descendants
- K242608: Embozene Color-Advanced Microspheres (2025), 0 descendants of its own

## Indications for use
Embozene Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids (UFE) and hepatoma, and for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH). This device is not intended for neurovascular use.

Source page: https://510kreport.com/device/K180102
Methodology: https://510kreport.com/methodology