Cleared Traditional

K143218 - Penumbra Smart Coil

K143218 is an FDA 510(k) clearance for Penumbra Smart Coil, manufactured by Penumbra, Inc.. The device is a Class 2 Neurology device with 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

FDA 510(k) Submission Details - K143218

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.

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 155
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K143218.
Axium Detachable Coil System
K151447 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jul 2015
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
AXIUM DETACHABLE COIL SYSTEM
K133310 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 2014