Entaxis Nasal Packing

FDA 510(k) K984069 · Les Laboratorires Brothier, S.A.

Substantially Equivalent

510(k) numberK984069

Submission

Device name
Entaxis Nasal Packing
Applicant
Les Laboratorires Brothier, S.A.
St Louis, MO, US
Received
November 16, 1998
Decision date
January 25, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
EMX – Balloon, Epistaxis
Device class
Class I (low risk)
Regulation
21 CFR 874.4100
Specialty
Ear, Nose, Throat

Other 510(k)s with product code EMX

510(k)DeviceApplicantDecision
K220326PosiSep X BAM Hemostat Dressing/Intranasal SplintEMX · Traditional Hemostasis, LLC11/14/2022SE
K041446NasalceaseEMX · Traditional Les Laboratorires Brothier, S.A.07/01/2004SE
K000108Rapid Rhino-Anterior 90MM, Model Rr-A 90, Rapid Rhino-Posterior 100MM, Model Rr-P 100EMX · Traditional Bhk Holding05/23/2000SE
K993362HylasineEMX · Traditional Biomatrix, Inc.03/13/2000SE
K983276Hydrofera Bacteristatic Nasal DressingEMX · Traditional Hydrofera, LLC09/14/1999SE
K982731Merogel Nasal Dressing and Sinus StentEMX · Traditional Xomed, Inc.02/02/1999SE
K981966Nosebleed NoseclipEMX · Traditional Michael M. Knott, M.D.08/14/1998SE
K973656Disposable Silicone Epistaxis CatheterEMX · Traditional Specialty Surgical Products, Inc.11/18/1997SE
K973085Ultracell Packing with SleeveEMX · Traditional Ultracell Medical Technologies, Inc.11/18/1997SE
K972922Vyker Silicone Epistaxis Catheter V-27030, Vyker Silicone Epistaxis Catheter Kit V-2703KEMX · Traditional Interview Medical Technology Corp.10/08/1997SE

More from Interview Medical Technology Corp.

510(k)DeviceDecision
K041446NasalceaseEMX · Traditional 07/01/2004SE
K922540Wound DressingKMF · Traditional 08/24/1992SE
K905314Algoderm Alginate Wound DressingFRO · Traditional 02/19/1991SE
K893123Adhesive Bandages & Pads for Minor Cuts/ScrapesQSY · Traditional 02/13/1990SE

Questions and answers

When was Entaxis Nasal Packing cleared by the FDA?

Entaxis Nasal Packing (K984069) received a 510(k) decision of Substantially Equivalent on January 25, 1999, 70 days after the submission was received.

What is the product code of K984069?

The FDA product code is EMX – Balloon, Epistaxis, a Class I (low risk) device regulated under 21 CFR 874.4100.