Cleared Traditional

Embozene Color-Advanced Microspheres (K180102) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence.

K180102 · Boston Scientific · Gastroenterology & Urology device
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Apr 2018
Decision
93d
Days
Class 2
Risk

K180102 is an FDA 510(k) clearance for the Embozene Color-Advanced Microspheres. Classified as Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (product code NOY), Class II - Special Controls.

Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on April 19, 2018 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5550 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific devices

Submission Details

510(k) Number K180102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2018
Decision Date April 19, 2018
Days to Decision 93 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 130d · This submission: 93d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Gastroenterology & Urology devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02206243 Completed Observational

Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia

An Observational Study to Evaluate the Safety and Efficacy of Embozene® Microspheres for Prostatic Arterial Embolization in Patients With Symptomatic Benign Prostatic Hyperplasia

300
Patients (actual)
1
Site
Condition studied Benign Prostatic Hyperplasia
Eligibility Male only · 40 Years+
Principal investigator Ulf Teichgräber, Prof.
Sponsor Jena University Hospital
Started 2014-09-01 → Primary completion 2018-11-01 → Completed 2019-02-01
Primary outcome
Symptomatic improvement of BPH symptoms (= International Prostate Symptom Score (IPSS) < 18 and reduction > 25% QoL (Quality of Life) < 4 & reduction ≥ & / or Qmax > 15 ml/s & increase of Qmax ≥ 3,0ml/s) at 6 and 12 months post intervention
Secondary outcome
Evaluate the safety of prostate artery embolization (PAE) for the treatment of lower urinary tract symptoms (LUTS) attributed to benign prostatic hyperplasia (BPH)
Study completed - no results published. This trial concluded in 2019 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

Regulatory Peers - NOY Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia

Devices cleared under the same product code (NOY) and FDA review panel - the closest regulatory comparables to K180102.
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 · Apr 2021
HydroPearl Microspheres
K192684 · MicroVention, Inc. · Jan 2020