FDA 510(k)

RhinAer® Stylus (FG1393)

Número K: K221907 · 2022-07-29

Data da decisão2022-07-29

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

RhinAer® Stylus (FG1393) 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 2022-07-29 under 510(k) number K221907. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the RhinAer® Stylus (FG1393)?

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

When did RhinAer® Stylus (FG1393) receive FDA 510(k) clearance?

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

Who is the listed applicant for RhinAer® Stylus (FG1393)?

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 (FG1393)?

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

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Fonte oficial

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