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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 / March 2026 / K254239

510(k) cleared

CyClean Cord

SS GLOBAL · Mar 27, 2026 · K254239

FDA cleared the CyClean Cord from SS GLOBAL on Mar 27, 2026 under K254239, a traditional 510(k). The device falls under product code MVL, Cord, Retraction as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Dec 29, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

SS GLOBAL has 2 other decisions in the tracker over the last 12 months: K262427 (Pen Needle (Ordinary Type I, Safety Type IIA, Safety Type IIB, Safety Type IIIA, Safety Type IIIB, Safety Type IV, Safety Type V, Ordinary Type VIA, Ordinary Type VIB, Ordinary Type VIC, Safety Type VII, Ordinary Type IB, Safety type VIII, Safety Type IX, Safety Type X, Ordinary Type XI, Safety Type XII)), K252886 (Pen Needle).

Questions & Answers

What did FDA clear under K254239?

K254239 is the FDA 510(k) for CyClean Cord, submitted by SS GLOBAL. FDA's decision date was Mar 27, 2026, under product code MVL (Cord, Retraction).

Who makes the CyClean Cord?

SS GLOBAL, based in Bucheon-Si, is the applicant of record for K254239.

How long did the K254239 review take?

FDA received the submission on Dec 29, 2025 and issued its decision on Mar 27, 2026, 88 days later.

← All decisions in March 2026