Cleared Traditional

K143218 - Penumbra Smart Coil

K143218 is the FDA 510(k) clearance for Penumbra Smart Coil by Penumbra, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K143218 · Penumbra, Inc. · Neurology device
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Mar 2015
Decision
128d
Days
Class 2
Risk

K143218 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 March 18, 2015 after a review of 128 days - within the typical 510(k) review window.

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 Penumbra, Inc. devices

Submission Details

510(k) Number K143218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 10, 2014
Decision Date March 18, 2015
Days to Decision 128 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
20d faster than avg
Panel avg: 148d · This submission: 128d
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 84
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K143218.
MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)
K153594 · MicroVention, Inc. · Jan 2016
Penumbra Smart Coil
K151572 · Penumbra, Inc. · Jul 2015
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS
K150319 · Codman & Shurtleff, Inc. · Jun 2015
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable
K142429 · Codman & Shurtleff, Inc. · Dec 2014
POD SYSTEM
K141134 · Penumbra, Inc. · Jul 2014
MICROPLEX COIL SYSTEM (MCS), HYDROCOIL EMBOLIC SYSTEM (HES)
K132952 · MicroVention, Inc. · Dec 2013