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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 / June 2026 / K260105

510(k) cleared

Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts

Edwards Lifesciences · Jun 5, 2026 · K260105

FDA cleared the Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts from Edwards Lifesciences on Jun 5, 2026 under K260105, a traditional 510(k). The device falls under product code DXC, Clamp, Vascular, regulated at 21 CFR 870.4450 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Jan 13, 2026. The decision came 143 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Edwards Lifesciences has 8 other decisions in the tracker over the last 12 months: K254232 (ECLIPTIS Left Atrial Appendage Exclusion System (ECS135); ECLIPTIS Left Atrial Appendage Exclusion System (ECS140); ECLIPTIS Left Atrial Appendage Exclusion System (ECS145); ECLIPTIS Left Atrial Appendage Exclusion System (ECS150)), K251326 (Respiration Rate algorithm), K254279 (Edwards eSheath+ introducer set), K253186 (HemoSphere Nano Monitor (HSNANO1)).

Questions & Answers

What did FDA clear under K260105?

K260105 is the FDA 510(k) for Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts, submitted by Edwards Lifesciences. FDA's decision date was Jun 5, 2026, under product code DXC (Clamp, Vascular).

Who makes the Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts?

Edwards Lifesciences, based in Irvine, CA, is the applicant of record for K260105.

How long did the K260105 review take?

FDA received the submission on Jan 13, 2026 and issued its decision on Jun 5, 2026, 143 days later.

← All decisions in June 2026