Cleared Special

K123560 - VASCULAR OCCLUSION SYSTEM (TRUFILL PUSH...

K123560 is the FDA 510(k) clearance for VASCULAR OCCLUSION SYSTEM (TRUFILL PUSH... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 67-day FDA review.

K123560 · Codman & Shurtleff, Inc. · Neurology device
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Jan 2013
Decision
67d
Days
Class 2
Risk

K123560 is an FDA 510(k) clearance for the VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DET.... 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 January 25, 2013 after a review of 67 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K123560 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2012
Decision Date January 25, 2013
Days to Decision 67 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
81d faster than avg
Panel avg: 148d · This submission: 67d
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 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K123560.
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013
MICROPLEX COIL SYSTEM (MCS)
K131948 · MicroVention, Inc. · Oct 2013
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc. · Sep 2013
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · MicroVention, Inc. · Apr 2012
ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
K120686 · Codman & Shurtleff, Inc. · Apr 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · Penumbra, Inc. · Apr 2012