NOY · Class II · 21 CFR 876.5550

FDA Product Code NOY: Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

The Device Comprises One Or More Objects Placed In A Blood Vessel To Permanently Obstruct Blood Flow To The Prostate To Treat Benign Prostatic Hyperplasia (bph).

Leading manufacturers include Biosphere Medical, S.A., Boston Scientific and MicroVention, Inc..

4
Total
3
Cleared
174d
Avg days
2017
Since

FDA 510(k) Cleared Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia Devices (Product Code NOY)

4 devices
1–4 of 4
Cleared Apr 20, 2021
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)
K203276
Biocompatibles UK Ltd (Part of Boston Scientific Corporation
Neurology · 165d
Cleared Jan 22, 2020
HydroPearl Microspheres
K192684
MicroVention, Inc.
Gastroenterology & Urology · 118d
Cleared Apr 19, 2018
Embozene Color-Advanced Microspheres
K180102
Boston Scientific
Gastroenterology & Urology · 93d
Not Cleared Jun 21, 2017
Embosphere Microspheres
DEN160040
Biosphere Medical, S.A.
Gastroenterology & Urology · 320d

About Product Code NOY - Regulatory Context