Cleared Traditional

K102365 - MICROPLEX COIL SYSTEM- COSMOS

K102365 is an FDA 510(k) clearance for MICROPLEX COIL SYSTEM- COSMOS, manufactured by MicroVention, Inc.. The device is a Class 2 Neurology device with product code KRD cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102365 · MicroVention, Inc. · Neurology device
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Nov 2010
Decision
90d
Days
Class 2
Risk

K102365 is an FDA 510(k) clearance for the MICROPLEX COIL SYSTEM- COSMOS. Classified as Device, Vascular, For Promoting Embolization (product code KRD), Class II - Special Controls.

Submitted by MicroVention, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 870.3300 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all MicroVention, Inc. devices

FDA 510(k) Submission Details - K102365

510(k) Number K102365 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2010
Decision Date November 18, 2010
Days to Decision 90 days
Submission Type Traditional
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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KRD Device Classification - Class 2, Special Controls

Product Code KRD Device, Vascular, For Promoting Embolization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3300
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 - KRD Device, Vascular, For Promoting Embolization

All 111
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