K163509 is an FDA 510(k) clearance for the XprESS ENT Dilation System. This device is classified as a Eustachian Tube Balloon Dilation Device (Class II - Special Controls, product code PNZ).
Submitted by Entellus Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on April 5, 2017, 111 days after receiving the submission on December 15, 2016.
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 | K163509 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 15, 2016 |
| Decision Date | April 05, 2017 |
| Days to Decision | 111 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. |