Cleared Traditional

K153658 - Target Detachable Coils

K153658 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 Traditional 510(k) pathway after a 150-day FDA review.

K153658 · Stryker Neurovascular · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2016
Decision
150d
Days
Class 2
Risk

K153658 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 May 19, 2016 after a review of 150 days - an extended review cycle.

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 Stryker Neurovascular devices

Submission Details

510(k) Number K153658 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 2015
Decision Date May 19, 2016
Days to Decision 150 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 148d · This submission: 150d
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 117
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K153658.
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