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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 / K261707

510(k) cleared

MEMO 4D Curve Semirigid mitral annuloplasty ring

Corcym S.r.l. · Jun 18, 2026 · K261707

FDA cleared the MEMO 4D Curve Semirigid mitral annuloplasty ring from Corcym S.r.l. on Jun 18, 2026 under K261707, a special 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 May 22, 2026. The decision came 27 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: K260498 (TriMemo SEMIRIGID ANNULOPLASTY RING).

Questions & Answers

What did FDA clear under K261707?

K261707 is the FDA 510(k) for MEMO 4D Curve Semirigid mitral annuloplasty ring, submitted by Corcym S.r.l.. FDA's decision date was Jun 18, 2026, under product code KRH (Ring, Annuloplasty).

Who makes the MEMO 4D Curve Semirigid mitral annuloplasty ring?

Corcym S.r.l., based in Saluggia, is the applicant of record for K261707.

How long did the K261707 review take?

FDA received the submission on May 22, 2026 and issued its decision on Jun 18, 2026, 27 days later.

← All decisions in June 2026

Sources