Apollo System
K-Number: K152699 · 2016-03-17
ApplicantPenumbra, Inc.
Decision Date2016-03-17
Product CodeGWG
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Apollo System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2016-03-17 under approval number K152699. 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 Apollo System?
Apollo System is a medical device that received FDA 510(k) clearance on 2016-03-17. It is manufactured by Penumbra, Inc.. The 510(k) number is K152699.
When was Apollo System approved by the FDA?
Apollo System received FDA 510(k) clearance on 2016-03-17, under approval number K152699.
What company makes Apollo System?
Apollo System is manufactured by Penumbra, Inc..
What is the FDA product code for Apollo System?
The FDA product code for Apollo System is GWG.
Related Clinical Trials
Other Devices by Penumbra, Inc.
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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.