Cleared Traditional

VersaWrap Nerve Protector

K232029 · Alafair Biosciences, Inc. · Neurology
Nov 2023
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K232029 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 November 2, 2023, 118 days after receiving the submission on July 7, 2023. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K232029 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2023
Decision Date November 02, 2023
Days to Decision 118 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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