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FDA 510(k)

Benchmark Intracranial Access System

K-Number: K212838 · 2022-05-27

ApplicantPenumbra, Inc.
Decision Date2022-05-27
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Benchmark Intracranial Access System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2022-05-27 under approval number K212838. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Benchmark Intracranial Access System?

Benchmark Intracranial Access System is a medical device that received FDA 510(k) clearance on 2022-05-27. It is manufactured by Penumbra, Inc.. The 510(k) number is K212838.

When was Benchmark Intracranial Access System approved by the FDA?

Benchmark Intracranial Access System received FDA 510(k) clearance on 2022-05-27, under approval number K212838.

What company makes Benchmark Intracranial Access System?

Benchmark Intracranial Access System is manufactured by Penumbra, Inc..

What is the FDA product code for Benchmark Intracranial Access System?

The FDA product code for Benchmark Intracranial Access System is QJP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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