Cleared Special

K160096 - InZone Detachment System

K160096 is an FDA 510(k) clearance for InZone Detachment System, manufactured by Stryker Neurovascular. 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.

K160096 · Stryker Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
31d
Days
Class 2
Risk

K160096 is an FDA 510(k) clearance for the InZone Detachment System. 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 February 19, 2016 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 Stryker Neurovascular devices

FDA 510(k) Submission Details - K160096

510(k) Number K160096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 2016
Decision Date February 19, 2016
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 169
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K160096.
Target Detachable Coils
K161429 · Stryker Neurovascular · Jun 2016
Target Detachable Coils
K153658 · Stryker Neurovascular · May 2016
Penumbra Smart Coil
K160832 · Penumbra, Inc. · Apr 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016
Axium Detachable Coil System
K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2015
Barricade Embolization Coil System
K151760 · Blockade Medical · Jul 2015