Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Eustachian Tube Balloon Dilation Device
510(k) Number K253612
Device Name Acclarent AERA Eustachian Tube Balloon Dilation System
Applicant
Acclarent, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Applicant Contact Kweku Biney
Correspondent
Acclarent, Inc.
31 Technology Dr. Suite 200
Irvine,  CA  92618
Correspondent Contact Kweku Biney
Regulation Number874.4180
Classification Product Code
PNZ  
Date Received11/18/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-