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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K253363

510(k) cleared

NeuroSpan Bridge

Auxilium Biotechnologies, Inc. · Jan 17, 2026 · K253363

FDA cleared the NeuroSpan Bridge from Auxilium Biotechnologies, Inc. on Jan 17, 2026 under K253363, a traditional 510(k). The device falls under product code JXI, Cuff, Nerve, regulated at 21 CFR 882.5275 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Sep 30, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Auxilium Biotechnologies, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253363?

K253363 is the FDA 510(k) for NeuroSpan Bridge, submitted by Auxilium Biotechnologies, Inc.. FDA's decision date was Jan 17, 2026, under product code JXI (Cuff, Nerve).

Who makes the NeuroSpan Bridge?

Auxilium Biotechnologies, Inc., based in Ann Arbor, MI, is the applicant of record for K253363.

How long did the K253363 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Jan 17, 2026, 109 days later.

← All decisions in January 2026