510(k) K253612 ยท PNZ Eustachian Tube Balloon Dilation Device
Acclarent AERA Eustachian Tube Balloon Dilation System
| Applicant | Acclarent, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Nov 18, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253612
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.