Cleared Traditional

K041381 - MEROPACK BIORESORBABLE NASAL PACKING AND SINUS STENT

K041381 is an FDA 510(k) clearance for MEROPACK BIORESORBABLE NASAL PACKING AN..., manufactured by Medtronic Xomed, Inc.. The device is a Class 1 Ear, Nose, Throat device with product code LYA cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K041381 · Medtronic Xomed, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K041381

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 90d · This submission: 108d
Pathway characteristics
Predicate-based equivalence.

LYA Device Classification - Class 1, General Controls

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.

Regulatory Peers - LYA Splint, Intranasal Septal

All 43
Devices cleared under the same product code (LYA) and FDA review panel - the closest regulatory comparables to K041381.
ADVACOAT SINUS GEL AND STENT
K070496 · Carbylan Biosurgery · Mar 2007
ADVACOAT SINUS GEL, MODEL 9100, ADVA SINUS STENT, MODEL 9200
K063308 · Carbylan Biosurgery · Dec 2006
NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZ
K052099 · Polyganics B.V., · Nov 2005
SEPRAGEL SINUS
K012532 · Genzyme Corp. · Oct 2001
HADGEL, 4 GRAM/SYRINGE
K011544 · Seikagaku Corp. · Aug 2001
LACTOSORB ETHMOID STENT
K002131 · Walter Lorenz Surgical, Inc. · Apr 2001