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

Eustachian Tube Balloon Dilation Device

21 CFR 874.4180 / Ear, Nose, Throat
FDA source (opens on fda.gov)

PNZ is the FDA product code for Eustachian Tube Balloon Dilation Device, a class II device type, regulated under 21 CFR 874.4180. FDA's definition for this code reads: "The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction". As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
PNZ
Device name
Eustachian Tube Balloon Dilation Device
FDA definition
The device is intended for use in dilating the cartilaginous portion of the Eustachian tube for treating persistent Eustachian tube dysfunction.
Regulation
21 CFR 874.4180
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code PNZ

By decision year
9 clearances under product code PNZ with a decision year between 2016 and 2026, 2023 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code PNZ by decision year
YearClearances
20161
20171
20181
20211
20221
20233
20261

Applicants with the most clearances

Product code PNZ
Applicants holding the most 510(k) clearances under product code PNZ
ApplicantClearances
Acclarent Inc4
Entellus Medical, Inc.2
Fiagon GmbH1
Medtronic Xomed, Inc.1
Spiggle & Theis Medizintechnik GmbH1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order