Cleared Traditional

Penumbra LP Coil System

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

About This 510(k) Submission

K230284 is an FDA 510(k) clearance for the Penumbra LP Coil System, a Device, Neurovascular Embolization (Class II — Special Controls, product code HCG), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on October 25, 2023, 265 days after receiving the submission on February 2, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5950.

Submission Details

510(k) Number K230284 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code HCG — Device, Neurovascular Embolization
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5950

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