Cleared Special

Penumbra Smart Coil (K160832) - FDA 510(k) Clearance

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K160832 · Penumbra, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
26d
Days
Class 2
Risk

K160832 is an FDA 510(k) clearance for the Penumbra Smart Coil. Classified as Device, Neurovascular Embolization (product code HCG), Class II - Special Controls.

Submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on April 20, 2016 after a review of 26 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 Penumbra, Inc. devices

Submission Details

510(k) Number K160832 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2016
Decision Date April 20, 2016
Days to Decision 26 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
122d faster than avg
Panel avg: 148d · This submission: 26d
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 84
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K160832.
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HydroCoil Embolic System (HES)
K161367 · MicroVention, Inc. · Aug 2016
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K161452 · MicroVention, Inc. · Aug 2016
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016
Penumbra Smart Coil
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K150319 · Codman & Shurtleff, Inc. · Jun 2015