# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Biocompatibles UK Ltd (Part of Boston Scientific Corporation
- Decided: Apr 20, 2021 after 165 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.
No later device cites it as a predicate yet.
0 of 2 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 5.

## Indications for use
Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).

Source page: https://510kreport.com/device/K203276
Methodology: https://510kreport.com/methodology