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 Boston Scientific, MicroVention, Inc. and Biocompatibles UK Ltd (Part of Boston Scientific Corporation.

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

About Product Code NOY - Regulatory Context