Cleared Traditional

Benchmark Intracranial Access System

K212838 · Penumbra, Inc. · Neurology

May 2022

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K212838 is an FDA 510(k) clearance for the Benchmark Intracranial Access System, a Catheter, Percutaneous, Neurovasculature (Class II — Special Controls, product code QJP), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on May 27, 2022, 262 days after receiving the submission on September 7, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number	K212838 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2021
Decision Date	May 27, 2022
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	QJP — Catheter, Percutaneous, Neurovasculature
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.1250
Definition	To Provide Vascular Access To The Neurovasculature For Interventional Or Diagnostic Procedures