510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K984069Substantially Equivalent

Entaxis Nasal Packing

Les Laboratorires Brothier, S.A., St Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984069 is the FDA 510(k) clearance record for ENTAXIS NASAL PACKING, a class I device, cleared for Les Laboratorires Brothier, S.A. on under FDA product code EMX (Balloon, Epistaxis). FDA records list 5 510(k) clearances for Les Laboratorires Brothier, S.A., from to . As of , FDA records show no recalls naming K984069.

Clearance record

Decision date
Received
(70 days to decision)
Product code
EMX Balloon, Epistaxis
Regulation
21 CFR 874.4100
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Les Laboratorires Brothier, S.A. 7527 Westmoreland Ave., St Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code EMX

Trailing 12 months

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

FDA records show no clearances under product code EMX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EMX, 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