510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230065Substantially Equivalent

VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System

Fiagon GmbH, Hennigsdorf, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230065 is the FDA 510(k) clearance record for VenSure™ Balloon Dilation System, VenSure™ Light Balloon Dilation System, VenSure™ Nav Balloon Dilation System, VenSure™ ET Balloon Dilation System, a class II device, cleared for Fiagon GmbH 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 16 510(k) clearances for Fiagon GmbH, from to . As of , FDA records show no recalls naming K230065.

Clearance record

Decision date
Received
(137 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
Fiagon GmbH Neuendorfst. 23b, Hennigsdorf, DE
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