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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 / April 2026 / K260245

510(k) cleared

SILKBridge

KLISBio S.r.l. · Apr 9, 2026 · K260245

FDA cleared the SILKBridge from KLISBio S.r.l. on Apr 9, 2026 under K260245, 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 Jan 27, 2026. The decision came 72 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for KLISBio S.r.l. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260245?

K260245 is the FDA 510(k) for SILKBridge, submitted by KLISBio S.r.l.. FDA's decision date was Apr 9, 2026, under product code JXI (Cuff, Nerve).

Who makes the SILKBridge?

KLISBio S.r.l., based in Bresso, is the applicant of record for K260245.

How long did the K260245 review take?

FDA received the submission on Jan 27, 2026 and issued its decision on Apr 9, 2026, 72 days later.

← All decisions in April 2026