Cleared Special

K091641 - HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AN...

K091641 is the FDA 510(k) clearance for HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AN... by MicroVention, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 26-day FDA review.

K091641 · MicroVention, Inc. · Neurology device
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Jun 2009
Decision
26d
Days
Class 2
Risk

K091641 is an FDA 510(k) clearance for the HYDROCOIL EMBOLIC SYSTEM (HYDROSOFT) AND MICROPLEX COIL SYSTEM (HYPERSOFT). Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on June 30, 2009 after a review of 26 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 K091641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2009
Decision Date June 30, 2009
Days to Decision 26 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
122d faster than avg
Panel avg: 148d · This submission: 26d
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 K091641.
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
K093919 · MicroVention, Inc. · Jan 2010
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V
K093358 · MicroVention, Inc. · Jan 2010
INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250
K092666 · Boston Scientific Corp · Sep 2009
MICROPLEX COIL SYSTEM-COSMOS
K090891 · MicroVention, Inc. · Jun 2009
HYDROFRAME (HES)
K090357 · MicroVention, Inc. · Apr 2009
AZUR DETACTABLE 18, MODELS 45-480305, 45-480310, 45-480405, 44-480415
K090168 · MicroVention, Inc. · Mar 2009