Cleared Special

DURAFORM Dural Graft Implant

K152481 · Codman & Shurtleff, Inc. · Neurology
Oct 2015
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K152481 is an FDA 510(k) clearance for the DURAFORM Dural Graft Implant, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on October 30, 2015, 60 days after receiving the submission on August 31, 2015. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number K152481 FDA.gov
FDA Decision Cleared SESE
Date Received August 31, 2015
Decision Date October 30, 2015
Days to Decision 60 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

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