Cleared Traditional

K203276 - 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) (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K203276 · Biocompatibles UK Ltd (Part of Boston Scientific Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
165d
Days
Class 2
Risk

K203276 is an FDA 510(k) clearance for the Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500.... Classified as Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (product code NOY), Class II - Special Controls.

Submitted by Biocompatibles UK Ltd (Part of Boston Scientific Corporation (Farnham, GB). The FDA issued a Cleared decision on April 20, 2021 after a review of 165 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 876.5550 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Biocompatibles UK Ltd (Part of Boston Scientific Corporation devices

Submission Details

510(k) Number K203276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d slower than avg
Panel avg: 148d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia
Device Class Class 2 - 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).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.