Cleared Special

RhinAer? Stylus (FG1393)

K221907 · Aerin Medical, Inc. · Ear, Nose, Throat

Jul 2022

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K221907 is an FDA 510(k) clearance for the RhinAer? Stylus (FG1393), a Electrosurgical, Cutting & Coagulation & Accessories (Class II — Special Controls, product code GEI), submitted by Aerin Medical, Inc. (Mountain View, US). The FDA issued a Cleared decision on July 29, 2022, 29 days after receiving the submission on June 30, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 878.4400.

Submission Details

510(k) Number	K221907 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 30, 2022
Decision Date	July 29, 2022
Days to Decision	29 days
Submission Type	Special
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF

Device Classification

Product Code	GEI — Electrosurgical, Cutting & Coagulation & Accessories
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4400
Definition	Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).