XprESS ENT Dilation System
FDA 510(k) K163509 · Entellus Medical, Inc.
510(k) numberK163509
Submission
- Device name
- XprESS ENT Dilation System
- Applicant
- Entellus Medical, Inc.
Plymouth, MN, US - Received
- December 15, 2016
- Decision date
- April 5, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PNZ – Eustachian Tube Balloon Dilation Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4180
- Specialty
- Ear, Nose, Throat
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Other 510(k)s with product code PNZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253612 | Acclarent AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | Acclarent, Inc. | 02/19/2026SE |
| K230742 | ACCLARENT AERA Eustachian Tube Dilation SystemPNZ · Traditional | Acclarent, Inc. | 12/13/2023SE |
| K223542 | TubaVent Balloon Dilatation SystemPNZ · Traditional | Spiggle & Theis Medizintechnik GmbH | 08/03/2023SE |
| K230065 | VenSure Balloon Dilation System, VenSure Light Balloon Dilation System, VenSure Nav…PNZ · Traditional | Fiagon GmbH | 05/26/2023SE |
| K220027 | Audion ET dilation systemPNZ · Traditional | Entellus Medical, Inc. | 04/12/2022SE |
| K210841 | NuVent Eustachian Tube Dilation BalloonPNZ · Traditional | Medtronic Xomed, Inc. | 08/16/2021SE |
| K171761 | ACCLARENT AERA Eustachian Tube Balloon Dilation SystemPNZ · Traditional | Acclarent, Inc. | 01/16/2018SE |
More from Acclarent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220027 | Audion ET dilation systemPNZ · Traditional | 04/12/2022SE |
| K163435 | Entellus Medical Reinforced Anesthesia NeedleBSP · Traditional | 04/05/2017SE |
| K152435 | PassAssist LED Light FiberLRC · Traditional | 11/20/2015SE |
| K152434 | XprESS Multi-Sinus Dilation SystemLRC · Traditional | 11/20/2015SE |
| K142252 | XprESS Multi-Sinus Dilation ToolLRC · Special | 10/17/2014SE |
| K141916 | Pathassist LED Light FiberLRC · Special | 08/07/2014SE |
| K133563 | Pathassist Light SeekerLRC · Special | 12/20/2013SE |
| K132440 | Xpress Multi-Sinus Dilation ToolLRC · Special | 10/04/2013SE |
| K130503 | Pathassist LED Light FiberLRC · Traditional | 06/11/2013SE |
| K121943 | Xpress Multi-Sinus Dilation ToolLRC · Special | 08/22/2012SE |
Questions and answers
When was XprESS ENT Dilation System cleared by the FDA?
XprESS ENT Dilation System (K163509) received a 510(k) decision of Substantially Equivalent on April 5, 2017, 111 days after the submission was received.
What is the product code of K163509?
The FDA product code is PNZ – Eustachian Tube Balloon Dilation Device, a Class II (moderate risk) device regulated under 21 CFR 874.4180.