K230742
- 510(k) number
- K230742
- Device name
- ACCLARENT AERA Eustachian Tube Dilation System
- Applicant
- Acclarent, Inc. CA · US
- Product code
- PNZ — Eustachian Tube Balloon Dilation Device
- Decision date
- 2023-12-13
- Date received
- 2023-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
PDFDownload 510(k) SummaryArchived here · 2.4 MB · U.S. public domain
Also available from FDA: K230742.pdf
Official FDA record: K230742
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.