Cleared Special

K123560 - VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM

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

K123560 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K123560

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.

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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K123560.
MICROPLEX COIL SYSTEM (MCS), VFC
K132317 · MicroVention, Inc. · Sep 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K131475 · Blockade Medical · Jul 2013
BARRICADE EMBOLIZATION COIL SYSTEM
K123338 · Blockade Medical · Mar 2013
TARGET DETACHABLE COIL
K123377 · Stryker Neurovascular · Nov 2012
HYDROCOIL EMBOLIC SYSTEM (HES)
K120908 · MicroVention, Inc. · Apr 2012
TARGET DETACHABLE COIL
K120850 · Stryker Neurovascular · Apr 2012