Cleared Traditional

Bead Block (100 - 300?m, 1ml), Bead Block (300 - 500?m, 1ml), Bead Block (500 - 700?m, 1ml), Bead Block (700 - 900?m, 1ml), Bead Block (900 - 1200?m, 1ml), Bead Block (100 - 300?m, 2ml), Bead Block (300 - 500?m, 2ml), Bead Block (500 - 700?m, 2ml), Bead Block (700 - 900?m, 2ml), Bead Block (900 - 1200?m, 2ml)

K203276 · Biocompatibles UK Ltd (Part of Boston Scientific Corporation · Neurology
Apr 2021
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K203276 is an FDA 510(k) clearance for the Bead Block (100 - 300?m, 1ml), Bead Block (300 - 500?m, 1ml), Bead Block (500 - 700?m, 1ml), Bead Block (700 - 900?m, 1ml), Bead Block (900 - 1200?m, 1ml), Bead Block (100 - 300?m, 2ml), Bead Block (300 - 500?m, 2ml), Bead Block (500 - 700?m, 2ml), Bead Block (700 - 900?m, 2ml), Bead Block (900 - 1200?m, 2ml), a Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (Class II — Special Controls, product code NOY), submitted by Biocompatibles UK Ltd (Part of Boston Scientific Corporation (Farnham, GB). The FDA issued a Cleared decision on April 20, 2021, 165 days after receiving the submission on November 6, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 876.5550.

Submission Details

510(k) Number K203276 FDA.gov
FDA Decision Cleared SESE
Date Received November 06, 2020
Decision Date April 20, 2021
Days to Decision 165 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code NOY — Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5550
Definition 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).