Cleared Traditional

K153658 - Target Detachable Coils

K153658 is an FDA 510(k) clearance for Target Detachable Coils, manufactured by Stryker Neurovascular. The device is a Class 2 Neurology device with 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)
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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

FDA 510(k) Submission Details - K153658

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
Combination Product No
PCCP Authorized No
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.

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 K153658.
HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016
MicroPlex Coil System (MCS) - HyperSoft 3D
K161452 · MicroVention, Inc. · Aug 2016
Target Detachable Coils
K161429 · Stryker Neurovascular · Jun 2016
Penumbra Smart Coil
K160832 · Penumbra, Inc. · Apr 2016
InZone Detachment System
K160096 · Stryker Neurovascular · Feb 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016