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FDA 510(k)

RhinAer® Stylus (FG1393)

K-Number: K221907 · 2022-07-29

ApplicantAerin Medical, Inc.
Decision Date2022-07-29
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RhinAer® Stylus (FG1393) is a medical device manufactured by Aerin Medical, Inc.. It received FDA 510(k) clearance on 2022-07-29 under approval number K221907. 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 RhinAer® Stylus (FG1393)?

RhinAer® Stylus (FG1393) is a medical device that received FDA 510(k) clearance on 2022-07-29. It is manufactured by Aerin Medical, Inc.. The 510(k) number is K221907.

When was RhinAer® Stylus (FG1393) approved by the FDA?

RhinAer® Stylus (FG1393) received FDA 510(k) clearance on 2022-07-29, under approval number K221907.

What company makes RhinAer® Stylus (FG1393)?

RhinAer® Stylus (FG1393) is manufactured by Aerin Medical, Inc..

What is the FDA product code for RhinAer® Stylus (FG1393)?

The FDA product code for RhinAer® Stylus (FG1393) is GEI.

Other Devices by Aerin Medical, 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.

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