Cleared Special

K132317 - MICROPLEX COIL SYSTEM (MCS), VFC

K132317 is an FDA 510(k) clearance for MICROPLEX COIL SYSTEM (MCS), 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 57-day FDA review.

K132317 · MicroVention, Inc. · Neurology device
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Sep 2013
Decision
57d
Days
Class 2
Risk

K132317 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM (MCS), VFC. 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 September 20, 2013 after a review of 57 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

FDA 510(k) Submission Details - K132317

510(k) Number K132317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2013
Decision Date September 20, 2013
Days to Decision 57 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
91d faster than avg
Panel avg: 148d · This submission: 57d
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 157
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K132317.
AXIUM DETACHABLE COIL SYSTEM
K133310 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2014
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc. · Oct 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
K123560 · Codman & Shurtleff, Inc. · Jan 2013
TARGET DETACHABLE COIL
K123377 · Stryker Neurovascular · Nov 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · MicroVention, Inc. · Apr 2012