Cleared Traditional

K984069 - ENTAXIS NASAL PACKING

K984069 is an FDA 510(k) clearance for ENTAXIS NASAL PACKING, manufactured by Les Laboratorires Brothier, S.A.. The device is a Class 1 Ear, Nose, Throat device with product code EMX cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K984069 · Les Laboratorires Brothier, S.A. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
70d
Days
Class 1
Risk

K984069 is an FDA 510(k) clearance for the ENTAXIS NASAL PACKING. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Les Laboratorires Brothier, S.A. (St Louis, US). The FDA issued a Cleared decision on January 25, 1999 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4100 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Les Laboratorires Brothier, S.A. devices

FDA 510(k) Submission Details - K984069

510(k) Number K984069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1998
Decision Date January 25, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 90d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

EMX Device Classification - Class 1, General Controls

Product Code EMX Balloon, Epistaxis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EMX Balloon, Epistaxis

All 30
Devices cleared under the same product code (EMX) and FDA review panel - the closest regulatory comparables to K984069.
HYLASINE
K993362 · Biomatrix, Inc. · Mar 2000
HYDROFERA BACTERISTATIC NASAL DRESSING
K983276 · Hydrofera, LLC · Sep 1999
MEROGEL NASAL DRESSING AND SINUS STENT
K982731 · Xomed, Inc. · Feb 1999
NOSEBLEED NOSECLIP
K981966 · Michael M. Knott, M.D. · Aug 1998
ULTRACELL PACKING WITH SLEEVE
K973085 · Ultracell Medical Technologies, Inc. · Nov 1997
DISPOSABLE SILICONE EPISTAXIS CATHETER
K973656 · Specialty Surgical Products, Inc. · Nov 1997