Cleared Traditional

K041381 - MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K041381 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
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Sep 2004
Decision
108d
Days
Class 1
Risk

K041381 is an FDA 510(k) clearance for the MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT. Classified as Splint, Intranasal Septal (product code LYA), Class I - General Controls.

Submitted by Medtronic Xomed, Inc. (Jacksonville, US). The FDA issued a Cleared decision on September 10, 2004 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4780 - 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 Medtronic Xomed, Inc. devices

Submission Details

510(k) Number K041381 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2004
Decision Date September 10, 2004
Days to Decision 108 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
19d slower than avg
Panel avg: 89d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LYA Splint, Intranasal Septal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4780
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.