InSeca ARC Stylus, Aerin Console
K-Number: K162810 · 2017-01-11
ApplicantAerin Medical, Inc.
Decision Date2017-01-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
InSeca ARC Stylus, Aerin Console is a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2017-01-11 under approval number K162810. 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 InSeca ARC Stylus, Aerin Console?
InSeca ARC Stylus, Aerin Console is a medical device that received FDA 510(k) clearance on 2017-01-11. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K162810.
When was InSeca ARC Stylus, Aerin Console approved by the FDA?
InSeca ARC Stylus, Aerin Console received FDA 510(k) clearance on 2017-01-11, under approval number K162810.
What company makes InSeca ARC Stylus, Aerin Console?
InSeca ARC Stylus, Aerin Console is manufactured by Aerin Medical, Inc..
What is the FDA product code for InSeca ARC Stylus, Aerin Console?
The FDA product code for InSeca ARC Stylus, 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.