Cleared Traditional

FLEXIBLE COOAGEN NERVE CUFF

K131541 · Collagen Matrix, Inc. · Neurology
Apr 2014
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K131541 is an FDA 510(k) clearance for the FLEXIBLE COOAGEN NERVE CUFF, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Collagen Matrix, Inc. (Oakland, US). The FDA issued a Cleared decision on April 3, 2014, 309 days after receiving the submission on May 29, 2013. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K131541 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 2013
Decision Date April 03, 2014
Days to Decision 309 days
Submission Type Traditional
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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