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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 / September 2025 / K251957

510(k) cleared

Coaptium Connect with Tissium Light

Tissium SA · Sep 8, 2025 · K251957

FDA cleared the Coaptium Connect with Tissium Light from Tissium SA on Sep 8, 2025 under K251957, a special 510(k). The device falls under product code SFD, In Situ Polymerizing Peripheral Nerve Repair Device, regulated at 21 CFR 882.5270 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Jun 25, 2025. The decision came 75 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Tissium SA in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251957?

K251957 is the FDA 510(k) for Coaptium Connect with Tissium Light, submitted by Tissium SA. FDA's decision date was Sep 8, 2025, under product code SFD (In Situ Polymerizing Peripheral Nerve Repair Device).

Who makes the Coaptium Connect with Tissium Light?

Tissium SA, based in Paris, is the applicant of record for K251957.

How long did the K251957 review take?

FDA received the submission on Jun 25, 2025 and issued its decision on Sep 8, 2025, 75 days later.

← All decisions in September 2025