ACCLARENT AERA Eustachian Tube Dilation System
K-Number: K230742 · 2023-12-13
ApplicantAcclarent, Inc.
Decision Date2023-12-13
Product CodePNZ
Advisory CommitteeEN
DecisionSubstantially Equivalent
Device Summary
ACCLARENT AERA Eustachian Tube Dilation System is a medical device manufactured by Acclarent, Inc.. It received FDA 510(k) clearance on 2023-12-13 under approval number K230742. The device is classified under product code PNZ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACCLARENT AERA Eustachian Tube Dilation System?
ACCLARENT AERA Eustachian Tube Dilation System is a medical device that received FDA 510(k) clearance on 2023-12-13. It is manufactured by Acclarent, Inc.. The 510(k) number is K230742.
When was ACCLARENT AERA Eustachian Tube Dilation System approved by the FDA?
ACCLARENT AERA Eustachian Tube Dilation System received FDA 510(k) clearance on 2023-12-13, under approval number K230742.
What company makes ACCLARENT AERA Eustachian Tube Dilation System?
ACCLARENT AERA Eustachian Tube Dilation System is manufactured by Acclarent, Inc..
What is the FDA product code for ACCLARENT AERA Eustachian Tube Dilation System?
The FDA product code for ACCLARENT AERA Eustachian Tube Dilation System is PNZ.
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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.