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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K260522
Device Name RhinAer+ Stylus
Applicant
Aerin Medical, Inc.
2565 Leghorn St.
Mountain View,,  CA  94043
Applicant Contact Teri Feeley
Correspondent
Aerin Medical, Inc.
2565 Leghorn St.
Mountain View,,  CA  94043
Correspondent Contact Teri Feeley
Regulation Number878.4400
Classification Product Code
GEI  
Date Received02/17/2026
Decision Date 05/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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