Cleared Special

K112181 - HYDROCOIL(R) EMBOLIC SYSTEM (HES)

K112181 is an FDA 510(k) clearance for HYDROCOIL EMBOLIC SYSTEM (HES), 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 126-day FDA review.

K112181 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K112181

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
23d faster than avg
Panel avg: 149d · This submission: 126d
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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K112181.
DELTAMAXX 18 MICROCOIL SYSTEM
K120274 · Codman and Shurtleff, Inc. · Mar 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K113457 · MicroVention, Inc. · Dec 2011
TARGET DETACHABLE COIL
K113412 · Stryker Neurovascular · 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
TRAGET DETACHABLE COIL
K112385 · Stryker Neurovascular · Sep 2011
K112181 · HYDROCOIL(R) EMBOLIC SYSTEM (HES)
Download PDF FDA Summary MicroVention, Inc.