510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163509Substantially Equivalent

XprESS ENT Dilation System

Entellus Medical, Inc., Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163509 is the FDA 510(k) clearance record for XprESS ENT Dilation System, a class II device, cleared for Entellus Medical, Inc. on under FDA product code PNZ (Eustachian Tube Balloon Dilation Device). FDA's definition for product code PNZ reads: "The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction". FDA records list 27 510(k) clearances for Entellus Medical, Inc., from to . As of , FDA records show no recalls naming K163509.

Clearance record

Decision date
Received
(111 days to decision)
Product code
PNZ Eustachian Tube Balloon Dilation Device
Regulation
21 CFR 874.4180
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Entellus Medical, Inc. 3600 Holly Ln. N., Suite 40, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNZ

Trailing 12 months
1 clearance under product code PNZ in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260