Cleared Special

K161429 - Target Detachable Coils

K161429 is the FDA 510(k) clearance for Target Detachable Coils by Stryker Neurovascular. It is a Class 2 Neurology device (product code HCG) cleared through the Special 510(k) pathway after a 30-day FDA review.

K161429 · Stryker Neurovascular · Neurology device
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Jun 2016
Decision
30d
Days
Class 2
Risk

K161429 is an FDA 510(k) clearance for the Target Detachable Coils. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on June 22, 2016 after a review of 30 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 Stryker Neurovascular devices

Submission Details

510(k) Number K161429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2016
Decision Date June 22, 2016
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 148d · This submission: 30d
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 117
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K161429.
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
Penumbra Smart Coil
K160832 · Penumbra, Inc. · Apr 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016
Penumbra Smart Coil
K151572 · Penumbra, Inc. · Jul 2015