Cleared Special

K083646 - MICRUS MICROCOLI SYSTEM

K083646 is an FDA 510(k) clearance for MICRUS MICROCOLI SYSTEM, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Neurology device with product code HCG cleared through the Special 510(k) pathway after a 24-day FDA review.

K083646 · Micrus Endovascular Corporation · Neurology device
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Jan 2009
Decision
24d
Days
Class 2
Risk

K083646 is an FDA 510(k) clearance for the MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (San Jose, US). The FDA issued a Cleared decision on January 2, 2009 after a review of 24 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 Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K083646

510(k) Number K083646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2008
Decision Date January 02, 2009
Days to Decision 24 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
124d faster than avg
Panel avg: 148d · This submission: 24d
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 144
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K083646.
HYDROFRAME (HES)
K090357 · MicroVention, Inc. · Apr 2009
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V-GRIP PLUS DETACHMENT CONTROLLER, MODEL VG503
K090001 · MicroVention, Inc. · Mar 2009
MICRUS MICROCOIL DELIVERY SYSTEM
K082739 · Micrus Endovascular Corporation · Oct 2008
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K082461 · MicroVention, Inc. · Oct 2008
TRUFILL DCS SYRINGE
K082324 · Cordis Neurovascular, Inc. · Sep 2008