Cleared Traditional

PuraSinus

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

About This 510(k) Submission

K183015 is an FDA 510(k) clearance for the PuraSinus, a Polymer, Ear, Nose And Throat, Synthetic, Absorbable (Class II — Special Controls, product code NHB), submitted by 3-D Matrix, Inc. (Needham, US). The FDA issued a Cleared decision on April 12, 2019, 163 days after receiving the submission on October 31, 2018. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number K183015 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code NHB — Polymer, Ear, Nose And Throat, Synthetic, Absorbable
Device Class Class II — 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.