Cleared Traditional

VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201)

K251175 · Alafair Biosciences · Neurology
Jul 2025
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K251175 is an FDA 510(k) clearance for the VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201), a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Alafair Biosciences (Austin, US). The FDA issued a Cleared decision on July 17, 2025, 92 days after receiving the submission on April 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K251175 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2025
Decision Date July 17, 2025
Days to Decision 92 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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