Cleared Special

K100454 - HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V

K100454 is an FDA 510(k) clearance for HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MOD..., 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 64-day FDA review.

K100454 · MicroVention, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
64d
Days
Class 2
Risk

K100454 is an FDA 510(k) clearance for the HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM.... 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 22, 2010 after a review of 64 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.

FDA 510(k) Submission Details - K100454

510(k) Number K100454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 2010
Decision Date April 22, 2010
Days to Decision 64 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
85d faster than avg
Panel avg: 149d · This submission: 64d
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 K100454.
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K093142 · Boston Scientific Corp · Feb 2010
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K093919 · MicroVention, Inc. · Jan 2010
K100454 · HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V
Download PDF FDA Summary MicroVention, Inc.