Cleared Special

K161452 - MicroPlex Coil System (MCS) - HyperSoft 3D

K161452 is an FDA 510(k) clearance for MicroPlex Coil System (MCS) - HyperSoft 3D, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 97-day FDA review.

K161452 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
97d
Days
Class 2
Risk

K161452 is an FDA 510(k) clearance for the MicroPlex Coil System (MCS) - HyperSoft 3D. 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 August 31, 2016 after a review of 97 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K161452

510(k) Number K161452 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 26, 2016
Decision Date August 31, 2016
Days to Decision 97 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
52d faster than avg
Panel avg: 149d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

HCG Device Classification - Class 2, Special Controls

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 185
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K161452.
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
K162999 · MicroVention, Inc. · Mar 2017
Axium Prime Detachable Coil System
K162704 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2017
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016
Target Detachable Coils
K161429 · Stryker Neurovascular · Jun 2016
Target Detachable Coils
K153658 · Stryker Neurovascular · May 2016
Penumbra Smart Coil
K160832 · Penumbra, Inc. · Apr 2016