Cleared Traditional

K253363 - NeuroSpan Bridge (FDA 510(k) Clearance)

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

K253363 · Auxilium Biotechnologies, Inc. · Neurology device
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Jan 2026
Decision
109d
Days
Class 2
Risk

K253363 is an FDA 510(k) clearance for the NeuroSpan Bridge. Classified as Cuff, Nerve (product code JXI), Class II - Special Controls.

Submitted by Auxilium Biotechnologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 17, 2026 after a review of 109 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 Auxilium Biotechnologies, Inc. devices

Submission Details

510(k) Number K253363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date January 17, 2026
Days to Decision 109 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
39d faster than avg
Panel avg: 148d · This submission: 109d
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 39
Devices cleared under the same product code (JXI) and FDA review panel - the closest regulatory comparables to K253363.
SILKBridge
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VersaCoat Nerve Protector (VTP-44G2)
K251505 · Alafair Biosciences · Jul 2025
VersaWrap Nerve Protector (VTP-2201)
K251175 · Alafair Biosciences · Jul 2025
Nerve Wrap (07-DW-001-TAB)
K242113 · Biocircuit Technologies, Inc. · Apr 2025
Remplir (ON-152, 15 x 20 mm)
K243889 · Orthocell, Ltd. · Apr 2025
Mochida Nerve Cuff
K233322 · Mochida Pharmaceutical Co., Ltd. · Jun 2024