Cleared Special

MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL (K122434) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K122434 · Medtronic Xomed · Ear, Nose, Throat device
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Oct 2012
Decision
82d
Days
Class 2
Risk

K122434 is an FDA 510(k) clearance for the MEROGEL INJECTABLE BIORESORBABLE NASAL DRESSING AND SINUS STENT AND OTOLOGIC GEL. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by Medtronic Xomed (Jacksonville, US). The FDA issued a Cleared decision on October 31, 2012 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3620 - the FDA ear, nose and throat device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Xomed devices

Submission Details

510(k) Number K122434 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 2012
Decision Date October 31, 2012
Days to Decision 82 days
Submission Type Special
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 89d · This submission: 82d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.3620
Definition Ear, Nose, And Throat Absorbable Synthetic Polymer Material Is A Device Material That Is Intended To Be Implanted For Use As A Space-occupying Substance In The Reconstructive Surgery Of The Head And Neck. The Device Is Shaped And Formed By The Surgeon To Conform To The Patient's Needs. This Generic Type Of Device Is Made Of Absorbable Synthetic Polymer Materials.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - NHB Polymer, Ear, Nose And Throat, Synthetic, Absorbable

All 14
Devices cleared under the same product code (NHB) and FDA review panel - the closest regulatory comparables to K122434.
SeptAlign
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LATERA Absorbable Nasal Implant System
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PuraSinus
K183015 · 3-D Matrix, Inc. · Apr 2019