Cleared Traditional

K173614 - Penumbra Coil 400

K173614 is an FDA 510(k) clearance for Penumbra Coil 400, 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 146-day FDA review.

K173614 · Penumbra, Inc. · Neurology device
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Apr 2018
Decision
146d
Days
Class 2
Risk

K173614 is an FDA 510(k) clearance for the Penumbra Coil 400, Ruby Coil System, POD System. 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 17, 2018 after a review of 146 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 - K173614

510(k) Number K173614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2017
Decision Date April 17, 2018
Days to Decision 146 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 faster than avg
Panel avg: 148d · This submission: 146d
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 149
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K173614.
Penumbra LP Coil System
K192955 · Penumbra, Inc. · Nov 2019
Spartan eCoil System
K180653 · Spartan Micro, Inc. · Dec 2018
Wallaby Avenir Coil System
K173711 · Wallaby Medical, Inc. · May 2018
Optima Coil System
K172390 · Blockade Medical, LLC (D.B.A. Balt Usa) · Feb 2018
GALAXY G3 Mini Microcoil Delivery System
K171862 · Codman & Shurtleff, Inc. · Sep 2017
POD Packing Coil
K170852 · Penumbra, Inc. · Jul 2017