Cleared Traditional

K183015 - PuraSinus (FDA 510(k) Clearance)

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K183015 · 3-D Matrix, Inc. · Ear, Nose, Throat device
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Apr 2019
Decision
163d
Days
Class 2
Risk

K183015 is an FDA 510(k) clearance for the PuraSinus. Classified as Polymer, Ear, Nose And Throat, Synthetic, Absorbable (product code NHB), Class II - Special Controls.

Submitted by 3-D Matrix, Inc. (Needham, US). The FDA issued a Cleared decision on April 12, 2019 after a review of 163 days - an extended review 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. 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.

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Submission Details

510(k) Number K183015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 2018
Decision Date April 12, 2019
Days to Decision 163 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
74d slower than avg
Panel avg: 89d · This submission: 163d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.