Cleared Traditional

VersaWrap Nerve Protector

K201631 · Alafair Biosciences, Inc. · Neurology
Sep 2020
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K201631 is an FDA 510(k) clearance for the VersaWrap Nerve Protector, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on September 14, 2020, 90 days after receiving the submission on June 16, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K201631 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2020
Decision Date September 14, 2020
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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