Cleared Special

DuraGen Secure Dural Regeneration Matrix

K163456 · Integra LifeSciences Corporation · Neurology
Jan 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K163456 is an FDA 510(k) clearance for the DuraGen Secure Dural Regeneration Matrix, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Integra LifeSciences Corporation (Planisboro, US). The FDA issued a Cleared decision on January 6, 2017, 28 days after receiving the submission on December 9, 2016. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K163456 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 2016
Decision Date January 06, 2017
Days to Decision 28 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXQ — Dura Substitute
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5910