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FDA 510(k)

Artemis Neuro Evacuation Device

K-Number: K171332 · 2017-08-14

ApplicantPenumbra, Inc.
Decision Date2017-08-14
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Artemis Neuro Evacuation Device is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2017-08-14 under 510(k) number K171332. The device is classified under product code GWG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artemis Neuro Evacuation Device?

Artemis Neuro Evacuation Device is a medical device that received FDA 510(k) clearance on 2017-08-14. The listed applicant is Penumbra, Inc.. The 510(k) number is K171332.

When did Artemis Neuro Evacuation Device receive FDA 510(k) clearance?

Artemis Neuro Evacuation Device received FDA 510(k) clearance on 2017-08-14, under 510(k) number K171332.

Who is the listed applicant for Artemis Neuro Evacuation Device?

The FDA 510(k) record lists Penumbra, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Artemis Neuro Evacuation Device?

The FDA product code for Artemis Neuro Evacuation Device is GWG.

Related Clinical Trials

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Other records listing Penumbra, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GWG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253602Precision S 4K SinuscopeStryker EndoscopyK253679Hydro Irrigation SystemStryker InstrumentsK243429HJY VisualNext 3D Endoscopic Vision SystemHjy Smart Medical Device Co., Ltd.K250752AURORA® Surgiscope® System (ASX15/60); AURORA® Surgiscope® System (ASX15/80)Integra LifeSciences CorporationK233391cCeLL - In vivoVPIX Medical, Inc.K223615Digital ClarusScope System, Digital NeuroPEN SystemClarus Medical, LLC

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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