Aerin Medical Stylus
K-Number: K161994 · 2016-09-22
ApplicantAerin Medical, Inc.
Decision Date2016-09-22
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Aerin Medical Stylus is a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2016-09-22 under approval number K161994. 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 Medical Stylus?
Aerin Medical Stylus is a medical device that received FDA 510(k) clearance on 2016-09-22. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K161994.
When was Aerin Medical Stylus approved by the FDA?
Aerin Medical Stylus received FDA 510(k) clearance on 2016-09-22, under approval number K161994.
What company makes Aerin Medical Stylus?
Aerin Medical Stylus is manufactured by Aerin Medical, Inc..
What is the FDA product code for Aerin Medical Stylus?
The FDA product code for Aerin Medical Stylus 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.