Cleared Special

K171747 - 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 is an FDA 510(k) clearance for MICRUSFRAME 10 Stretch Resistant Microc..., 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 31-day FDA review.

K171747 · Codman & Shurtleff, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
31d
Days
Class 2
Risk

K171747 is an FDA 510(k) clearance for the MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 S.... 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 July 14, 2017 after a review of 31 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 - K171747

510(k) Number K171747 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2017
Decision Date July 14, 2017
Days to Decision 31 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
117d faster than avg
Panel avg: 148d · This submission: 31d
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 158
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K171747.
Optima Coil System
K172390 · Blockade Medical, LLC (D.B.A. Balt Usa) · Feb 2018
GALAXY G3 Mini Microcoil Delivery System
K171862 · Codman & Shurtleff, Inc. · Sep 2017
POD Packing Coil
K170852 · Penumbra, 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
Axium Prime Detachable Coil System
K162704 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2017
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016