Cleared Traditional

K230284 - Penumbra LP Coil System

K230284 is an FDA 510(k) clearance for Penumbra LP Coil System, 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 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

FDA 510(k) Submission Details - K230284

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.

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 169
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