Cleared Special

K120908 - HYDROCOIL EMBOLIC SYSTEM (HES)

K120908 is the FDA 510(k) clearance for HYDROCOIL EMBOLIC SYSTEM (HES) by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 30-day FDA review.

K120908 · MicroVention, Inc. · Neurology device
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Apr 2012
Decision
30d
Days
Class 2
Risk

K120908 is an FDA 510(k) clearance for the 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 April 25, 2012 after a review of 30 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 K120908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2012
Decision Date April 25, 2012
Days to Decision 30 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
118d faster than avg
Panel avg: 148d · This submission: 30d
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 93
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K120908.
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc. · Oct 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc. · Sep 2013
VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM
K123560 · Codman & Shurtleff, Inc. · Jan 2013
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · Codman & Shurtleff, Inc. · Apr 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · Penumbra, Inc. · Apr 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · MicroVention, Inc. · Dec 2011