Cleared Special

K171747 - MICRUSFRAME 10 Stretch Resistant Microc...

K171747 is the FDA 510(k) clearance for MICRUSFRAME 10 Stretch Resistant Microc... by Codman & Shurtleff, Inc.. It is a Class 2 Neurology device (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

Submission Details

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.

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 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
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · MicroVention, Inc. · Aug 2016