Cleared Traditional

VersaWrap Nerve Protector (K232029) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K232029 is an FDA 510(k) clearance for the VersaWrap Nerve Protector. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Alafair Biosciences, Inc. (Austin, US). The FDA issued a Cleared decision on November 2, 2023 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5275 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Alafair Biosciences, Inc. devices

Submission Details

510(k) Number K232029 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 148d · This submission: 118d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JXI Cuff, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5275
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - JXI Cuff, Nerve

All 16
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K232029.
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024
NerveTape
K233533 · Biocircuit Technologies, Inc. · Feb 2024
Rebuilder Nerve Guidance Conduit
K230794 · Celestray Biotech Company, LLC., · Jan 2024
Axoguard HA+ Nerve Protector (AGHA12)
K231708 · Axogen Corporation · Oct 2023
Axoguard HA+ Nerve Protector (AGHA12)
K223640 · Axogen Corporation · Apr 2023
Nerve Tape
K210665 · Biocircuit Technologies, Incorporated · Jul 2022