K230742 is an FDA 510(k) clearance for the ACCLARENT AERA Eustachian Tube Dilation System. This device is classified as a Eustachian Tube Balloon Dilation Device (Class II - Special Controls, product code PNZ).
Submitted by Acclarent, Inc. (Irvine, US). The FDA issued a Cleared decision on December 13, 2023, 271 days after receiving the submission on March 17, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4180. The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction..
| 510(k) Number | K230742 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 2023 |
| Decision Date | December 13, 2023 |
| Days to Decision | 271 days |
| Submission Type | Traditional |
| Review Panel | Ear, Nose, Throat (EN) |
| Summary | Summary PDF |
| Product Code | PNZ — Eustachian Tube Balloon Dilation Device |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 874.4180 |
| Definition | The Device Is Intended For Use In Dilating The Cartilaginous Portion Of The Eustachian Tube For Treating Persistent Eustachian Tube Dysfunction. |