Cleared Traditional

K171862 - GALAXY G3 Mini Microcoil Delivery System

K171862 is the FDA 510(k) clearance for GALAXY G3 Mini Microcoil Delivery System by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K171862 · Codman & Shurtleff, Inc. · Neurology device
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Sep 2017
Decision
95d
Days
Class 2
Risk

K171862 is an FDA 510(k) clearance for the GALAXY G3 Mini 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 September 25, 2017 after a review of 95 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. 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 Codman & Shurtleff, Inc. devices

Submission Details

510(k) Number K171862 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2017
Decision Date September 25, 2017
Days to Decision 95 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
53d faster than avg
Panel avg: 148d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K171862.
Wallaby Avenir Coil System
K173711 · Wallaby Medical, Inc. · May 2018
Penumbra Coil 400, Ruby Coil System, POD System
K173614 · Penumbra, Inc. · Apr 2018
Optima Coil System
K172390 · Blockade Medical, LLC (D.B.A. Balt Usa) · Feb 2018
POD Packing Coil
K170852 · Penumbra, Inc. · Jul 2017
MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch Resistant Microcoil Delivery System, DELTAFILL 18 Stretch Resistant Microcoil Delivery System, DELTAXSFT 10 Stretch Resistant Microcoil Delivery System, GALAXY G3 FILL and GALAXY G3 XSFT Stretch Resistant Microcoil Delivery System
K171747 · Codman & Shurtleff, Inc. · Jul 2017
V-Grip Detachment Controller for use with Hydrocoil Embolic System and MicroPlex Coil System, AZUR Detachment Controller for use with AZUR Peripheral Coil System
K162999 · MicroVention, Inc. · Mar 2017