Cleared Traditional

Reinforced Flexible Collagen Nerve Cuff

K170656 · Collagen Matrix, Inc. · Neurology
Jun 2017
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K170656 is an FDA 510(k) clearance for the Reinforced Flexible Collagen 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 June 1, 2017, 90 days after receiving the submission on March 3, 2017. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K170656 FDA.gov
FDA Decision Cleared SESE
Date Received March 03, 2017
Decision Date June 01, 2017
Days to Decision 90 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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