Cleared Traditional

K230284 - Penumbra LP Coil System

K230284 is the FDA 510(k) clearance for Penumbra LP Coil System by Penumbra, Inc.. It is a Class 2 Neurology device (product code HCG) cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K230284 · Penumbra, Inc. · Neurology device
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Oct 2023
Decision
265d
Days
Class 2
Risk

K230284 is an FDA 510(k) clearance for the Penumbra LP Coil 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 October 25, 2023 after a review of 265 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 Penumbra, Inc. devices

Submission Details

510(k) Number K230284 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 02, 2023
Decision Date October 25, 2023
Days to Decision 265 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
117d slower than avg
Panel avg: 148d · This submission: 265d
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 116
Devices cleared under the same product code (HCG) and FDA review panel - the closest regulatory comparables to K230284.
Target Detachable Coils
K242243 · Stryker Neurovscular · Aug 2024
Numen Coil Embolization System
K232955 · MicroPort NeuroTech (Shanghai) Co., Ltd. · Jan 2024
Axium Detachable Coil
K233420 · Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular · Nov 2023
Target Tetra Detachable Coils
K222533 · Stryker Neurovascular · Dec 2022
Optima Coil System
K223386 · Balt USA, LLC · Dec 2022
CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL, Heliform XtraSoft XL, Freeform, Freeform Mini, and Freeform XtraSoft Detachable Coil Systems
K220040 · Medos International SARL · Jul 2022