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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 / K260498

510(k) cleared

TriMemo SEMIRIGID ANNULOPLASTY RING

Corcym S.r.l. · Apr 14, 2026 · K260498

FDA cleared the TriMemo SEMIRIGID ANNULOPLASTY RING from Corcym S.r.l. on Apr 14, 2026 under K260498, a abbreviated 510(k). The device falls under product code KRH, Ring, Annuloplasty, regulated at 21 CFR 870.3800 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Feb 13, 2026. The decision came 60 days later, inside the 90 FDA-day goal for a 510(k).

Corcym S.r.l. has one other decision in the tracker over the last 12 months: K261707 (MEMO 4D Curve Semirigid mitral annuloplasty ring).

Questions & Answers

What did FDA clear under K260498?

K260498 is the FDA 510(k) for TriMemo SEMIRIGID ANNULOPLASTY RING, submitted by Corcym S.r.l.. FDA's decision date was Apr 14, 2026, under product code KRH (Ring, Annuloplasty).

Who makes the TriMemo SEMIRIGID ANNULOPLASTY RING?

Corcym S.r.l., based in Saluggia, is the applicant of record for K260498.

How long did the K260498 review take?

FDA received the submission on Feb 13, 2026 and issued its decision on Apr 14, 2026, 60 days later.

← All decisions in April 2026

Sources