Cleared Special

K120686 - ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM

K120686 is an FDA 510(k) clearance for ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM, 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 29-day FDA review.

K120686 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
29d
Days
Class 2
Risk

K120686 is an FDA 510(k) clearance for the ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM. 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 April 4, 2012 after a review of 29 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.

FDA 510(k) Submission Details - K120686

510(k) Number K120686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2012
Decision Date April 04, 2012
Days to Decision 29 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
120d faster than avg
Panel avg: 149d · This submission: 29d
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 186
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K120686.
TARGET DETACHABLE COIL
K123377 · Stryker Neurovascular · Nov 2012
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K120908 · MicroVention, Inc. · Apr 2012
TARGET DETACHABLE COIL
K120850 · Stryker Neurovascular · Apr 2012
PENUMBRA COIL SYSTEM/PENUMBRA COIL 400
K120330 · Penumbra, Inc. · Apr 2012
QUADRASPHERE 30 TO 60
K113822 · Biosphere Medical, Inc. · Mar 2012
DELTAMAXX 18 MICROCOIL SYSTEM
K120274 · Codman and Shurtleff, Inc. · Mar 2012
K120686 · ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM
Download PDF FDA Summary Codman & Shurtleff, I…