The following data is part of a premarket notification filed by Entellus Medical, Inc. with the FDA for Xpress Ent Dilation System.
| Device ID | K163509 |
| 510k Number | K163509 |
| Device Name: | XprESS ENT Dilation System |
| Classification | Eustachian Tube Balloon Dilation Device |
| Applicant | Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Contact | Karen E. Peterson |
| Correspondent | Karen E. Peterson Entellus Medical, Inc. 3600 Holly Lane North, Suite 40 Plymouth, MN 55447 |
| Product Code | PNZ |
| CFR Regulation Number | 874.4180 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-15 |
| Decision Date | 2017-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857326005147 | K163509 | 000 |
| 00857326005017 | K163509 | 000 |
| 00857326005024 | K163509 | 000 |
| 00857326005031 | K163509 | 000 |
| 00857326005048 | K163509 | 000 |
| 00857326005055 | K163509 | 000 |
| 00857326005062 | K163509 | 000 |
| 00857326005079 | K163509 | 000 |
| 00857326005116 | K163509 | 000 |
| 00857326005123 | K163509 | 000 |
| 00857326005130 | K163509 | 000 |
| 00857326005000 | K163509 | 000 |