XprESS ENT Dilation System

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K163509 ↗

FDA Product Code

PNZ

FDA applicant

Entellus Medical, Inc.

Device Class

Class II

Regulation

21 CFR Part 874.4180

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Pathassist Light Seeker

  Class I

  FDA 510(k) K133563 Active Cleared 20 Dec 2013

• PassAssist LED Light Fiber

  Class I

  FDA 510(k) K152435 Active Cleared 20 Nov 2015

• Xpress Multi-Sinus Dilation Tool

  Class I

  FDA 510(k) K121174 Active Cleared 17 May 2012

• Pathassist Light Fiber

  Class I

  FDA 510(k) K111763 Active Cleared 15 Sep 2011

• Entellus Medical Sinus Guidewire

  Class I

  FDA 510(k) K110739 Active Cleared 14 Jun 2011

• Finess Endoscope

  Class II

  FDA 510(k) K102366 Active Cleared 15 Feb 2011

See all devices from Entellus Medical, Inc →