Cleared Traditional

NeuroSpan Bridge

K253363 · Auxilium Biotechnologies, Inc. · Neurology

Jan 2026

Decision

109d

Days

Class 2

Risk

About This 510(k) Submission

K253363 is an FDA 510(k) clearance for the NeuroSpan Bridge, a Cuff, Nerve (Class II — Special Controls, product code JXI), submitted by Auxilium Biotechnologies, Inc. (Ann Arbor, US). The FDA issued a Cleared decision on January 17, 2026, 109 days after receiving the submission on September 30, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5275.

Submission Details

510(k) Number	K253363 FDA.gov
FDA Decision	Cleared 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