Cleared Traditional

VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)

K251505 · Alafair Biosciences · Neurology
Jul 2025
Decision
67d
Days
Class 2
Risk

About This 510(k) Submission

K251505 is an FDA 510(k) clearance for the VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1), a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Alafair Biosciences (Austin, US). The FDA issued a Cleared decision on July 22, 2025, 67 days after receiving the submission on May 16, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number K251505 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 2025
Decision Date July 22, 2025
Days to Decision 67 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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