Cleared Special

K153594 - MicroPlex Coil System (MCS)

K153594 is the FDA 510(k) clearance for MicroPlex Coil System (MCS) by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 37-day FDA review.

K153594 · MicroVention, Inc. · Neurology device
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Jan 2016
Decision
37d
Days
Class 2
Risk

K153594 is an FDA 510(k) clearance for the MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES). Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on January 22, 2016 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5950 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all MicroVention, Inc. devices

Submission Details

510(k) Number K153594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2015
Decision Date January 22, 2016
Days to Decision 37 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 148d · This submission: 37d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HCG Device, Neurovascular Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5950
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.

Regulatory Peers - HCG Device, Neurovascular Embolization

All 84
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K153594.
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · MicroVention, Inc. · Aug 2016
Penumbra Smart Coil
K160832 · Penumbra, Inc. · Apr 2016
Penumbra Smart Coil
K151572 · Penumbra, Inc. · Jul 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K150319 · Codman & Shurtleff, Inc. · Jun 2015
Penumbra Smart Coil
K143218 · Penumbra, Inc. · Mar 2015