Cleared Special

NeuraGen 3D Nerve Guide Matrix

K163457 · Integra LifeSciences Corporation · Neurology
Jan 2017
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K163457 is an FDA 510(k) clearance for the NeuraGen 3D Nerve Guide Matrix, a Cuff, Nerve (Class II — Special Controls, product code JXI), 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 882.5275.

Submission Details

510(k) Number K163457 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 JXI — Cuff, Nerve
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.5275

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