Cleared Special

K142429 - CODMAN Microcoil Delivery System

K142429 is the FDA 510(k) clearance for CODMAN Microcoil Delivery System by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 117-day FDA review.

K142429 · Codman & Shurtleff, Inc. · Neurology device
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Dec 2014
Decision
117d
Days
Class 2
Risk

K142429 is an FDA 510(k) clearance for the CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT .... Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on December 24, 2014 after a review of 117 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.

View all Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K142429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2014
Decision Date December 24, 2014
Days to Decision 117 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
31d faster than avg
Panel avg: 148d · This submission: 117d
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 93
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K142429.
Penumbra Smart Coil
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Penumbra Smart Coil
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MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013
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K131948 · MicroVention, Inc. · Oct 2013