K253612
- 510(k) number
- K253612
- Device name
- Acclarent AERA Eustachian Tube Balloon Dilation System
- Applicant
- Acclarent, Inc. CA · US
- Product code
- PNZ — Eustachian Tube Balloon Dilation Device
- Decision date
- 2026-02-19
- Date received
- 2025-11-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K253612.pdf
Official FDA record: K253612
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.