# DEN160040: Embosphere Microspheres

- Pathway: De Novo (Direct)
- Applicant: Biosphere Medical, S.A.
- Decided: Jun 21, 2017 after 320 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
No predicates in its family tree.
4 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K180102: Embozene Color-Advanced Microspheres (2018), 1 descendant of its own
- K242608: Embozene Color-Advanced Microspheres (2025), 0 descendants of its own
- K203276: Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml) (2021), 0 descendants of its own
- K192684: HydroPearl Microspheres (2020), 0 descendants of its own

## Indications for use
Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, including symptomatic uterine fibroids, and prostatic arteries for symptomatic benign prostatic hyperplasia (BPH).

Source page: https://510kreport.com/device/DEN160040
Methodology: https://510kreport.com/methodology