Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

FDA product code NOY · 3 cleared devices

Class 2 Gastroenterology, Urology

Regulation: 21 CFR 876.5550
Review panel: GU
Implant: Yes
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2018-04-19 – 2021-04-20

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).

NOY 2021-04-20

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)

Applicant Biocompatibles UK Ltd (Part of Boston Scientific Corporation

K number K203276

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NOY 2020-01-22

HydroPearl Microspheres

Applicant MicroVention, Inc.

K number K192684

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NOY 2018-04-19

Embozene Color-Advanced Microspheres

Applicant Boston Scientific

K number K180102

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