Cleared Special

K112181 - HYDROCOIL EMBOLIC SYSTEM (HES)

K112181 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 126-day FDA review.

K112181 · MicroVention, Inc. · Neurology device
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Dec 2011
Decision
126d
Days
Class 2
Risk

K112181 is an FDA 510(k) clearance for the HYDROCOIL(R) 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 December 1, 2011 after a review of 126 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.

View all MicroVention, Inc. devices

Submission Details

510(k) Number K112181 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 2011
Decision Date December 01, 2011
Days to Decision 126 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
22d faster than avg
Panel avg: 148d · This submission: 126d
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 104
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K112181.
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
HYDROCOIL EMBOLIC SYSTEM (HES)
K112226 · MicroVention, Inc. · Sep 2011
MICROPLEX COIL SYSTEM-VECTOR MODEL 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V, 061030XXX-V, 101530XXX-V, 101540XX
K111451 · MicroVention, Inc. · Sep 2011
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
K103758 · MicroVention, Inc. · Apr 2011