510(k) K203276

Device

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), B

Applicant

Biocompatibles UK Ltd (Part of Boston Scientific Corporation

510(k) number

K203276

Product code

NOY

Decision

Substantially Equivalent (SESE)

Decision date

2021-04-20

Date received

2020-11-06

Regulation

876.5550

Classification name

Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Medical specialty

Gastroenterology, Urology

Review panel

Gastroenterology, Urology

Device class

2

Clearance type

Traditional

Statement or summary

Summary

Third party reviewed

No