Acclarent AERA Eustachian Tube Balloon Dilation System— 510(k) K253612
Substantially EquivalentAcclarent, Inc.
FDA 510(k) clearance K253612 for Acclarent AERA Eustachian Tube Balloon Dilation System, Substantially Equivalent on 2026-02-19. Applicant: Acclarent, Inc.. Device class: 2.
Clearance details
- Applicant
- Acclarent, Inc.
- Product code
- Code PNZ
- Device class
- Class 2
- Regulation
- 21 CFR 874.4180
- Advisory panel
- Ear, Nose, Throat
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code PNZ
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- K220027 — Audion ET dilation system
- K210841 — NuVent Eustachian Tube Dilation Balloon
More clearances from Acclarent, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.