Cleared Traditional

K982731 - MEROGEL NASAL DRESSING AND SINUS STENT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K982731 · Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1999
Decision
181d
Days
Class 1
Risk

K982731 is an FDA 510(k) clearance for the MEROGEL NASAL DRESSING AND SINUS STENT. Classified as Balloon, Epistaxis (product code EMX), Class I - General Controls.

Submitted by Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 2, 1999 after a review of 181 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Xomed, Inc. devices

Submission Details

510(k) Number K982731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1998
Decision Date February 02, 1999
Days to Decision 181 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 89d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.