Aerin Console
K-Number: K242630 · 2024-12-10
ApplicantAerin Medical, Inc.
Decision Date2024-12-10
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Aerin Console is a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2024-12-10 under approval number K242630. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Aerin Console?
Aerin Console is a medical device that received FDA 510(k) clearance on 2024-12-10. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K242630.
When was Aerin Console approved by the FDA?
Aerin Console received FDA 510(k) clearance on 2024-12-10, under approval number K242630.
What company makes Aerin Console?
Aerin Console is manufactured by Aerin Medical, Inc..
What is the FDA product code for Aerin Console?
The FDA product code for Aerin Console is GEI.
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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.