Cleared Traditional

K231708 - Axoguard HA+ Nerve Protector (AGHA12)

Also marketed or referenced as:
Axoguard HA+ Nerve Protector (AGHA22) Axoguard HA+ Nerve Protector (AGHA24) Axoguard HA+ Nerve Protector (AGHA36) Axoguard HA+ Nerve Protector (AGHA48)

K231708 is an FDA 510(k) clearance for Axoguard HA+ Nerve Protector (AGHA12), manufactured by Axogen Corporation. The device is a Class 2 Neurology device with product code JXI cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K231708 · Axogen Corporation · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2023
Decision
122d
Days
Class 2
Risk

K231708 is an FDA 510(k) clearance for the Axoguard HA+ Nerve Protector (AGHA12). Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Axogen Corporation (Alachua, US). The FDA issued a Cleared decision on October 12, 2023 after a review of 122 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 Axogen Corporation devices

FDA 510(k) Submission Details - K231708

510(k) Number K231708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2023
Decision Date October 12, 2023
Days to Decision 122 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
26d faster than avg
Panel avg: 148d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JXI Device Classification - Class 2, Special Controls

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 26
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K231708.
NerveTape
K233533 · Biocircuit Technologies, Inc. · Feb 2024
Rebuilder Nerve Guidance Conduit
K230794 · Celestray Biotech Company, LLC., · Jan 2024
VersaWrap Nerve Protector
K232029 · Alafair Biosciences, Inc. · Nov 2023
Axoguard HA+ Nerve Protector (AGHA12)
K223640 · Axogen Corporation · Apr 2023
Nerve Tape
K210665 · Biocircuit Technologies, Incorporated · Jul 2022
NervAlign Nerve Cuff
K202234 · Renerve, Ltd. · Feb 2022