Not Cleared Direct

DEN160040 - Embosphere Microspheres (FDA 510(k) Clearance)

Class II Gastroenterology & Urology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160040 · Biosphere Medical, S.A. · Gastroenterology & Urology device
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Jun 2017
Decision
320d
Days
Class 2
Risk

DEN160040 is an FDA 510(k) submission (not cleared) for the Embosphere Microspheres. Classified as Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia (product code NOY), Class II - Special Controls.

Submitted by Biosphere Medical, S.A. (383 Rue De La Belle Etoile, FR). The FDA issued a Not Cleared (DENG) decision on June 21, 2017 after a review of 320 days.

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 requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 320 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Biosphere Medical, S.A. devices

Submission Details

510(k) Number DEN160040 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received August 05, 2016
Decision Date June 21, 2017
Days to Decision 320 days
Submission Type Direct
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 130d · This submission: 320d
Pathway characteristics

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 Gastroenterology & Urology devices follow this clearance model.

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 DEN160040.
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