510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K201472Substantially Equivalent

VenSure Balloon Device, VenSure Nav Balloon Device

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

K201472 is the FDA 510(k) clearance record for VenSure Balloon Device, VenSure Nav Balloon Device, a class I device, cleared for Fiagon GmbH on under FDA product code LRC (Instrument, Ent Manual Surgical). FDA records list 16 510(k) clearances for Fiagon GmbH, from to . As of , FDA records show no recalls naming K201472.

Clearance record

Decision date
Received
(84 days to decision)
Product code
LRC Instrument, Ent Manual Surgical
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Fiagon GmbH Neuendorfstr. 23b, Hennigsdorf, DE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LRC

Trailing 12 months

FDA records hold no clearances under product code LRC in the trailing twelve months.

FDA records show no clearances under product code LRC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LRC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260