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FDA 510(k)

RhinAer+ Stylus

K-Number: K260522 · 2026-05-18

ApplicantAerin Medical, Inc.
Decision Date2026-05-18
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RhinAer+ Stylus is the device name listed in this FDA 510(k) record. The listed applicant is Aerin Medical, Inc.. It received FDA 510(k) clearance on 2026-05-18 under 510(k) number K260522. 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?

RhinAer+ Stylus is a medical device that received FDA 510(k) clearance on 2026-05-18. The listed applicant is Aerin Medical, Inc.. The 510(k) number is K260522.

When did RhinAer+ Stylus receive FDA 510(k) clearance?

RhinAer+ Stylus received FDA 510(k) clearance on 2026-05-18, under 510(k) number K260522.

Who is the listed applicant for RhinAer+ Stylus?

The FDA 510(k) record lists Aerin Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RhinAer+ Stylus?

The FDA product code for RhinAer+ Stylus is GEI.

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Other records listing Aerin Medical, Inc. as applicant

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K242630Aerin ConsoleK240253Reach NeedleK221907RhinAer® Stylus (FG1393)K200300VivAer StylusK192471RHIN1 StylusK172529Vivaer ARC Stylus

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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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