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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 / May 2026 / K261374

510(k) cleared

LigaPASS System

Medicrea International S.A.S · May 27, 2026 · K261374

FDA cleared the LigaPASS System from Medicrea International S.A.S on May 27, 2026 under K261374, a special 510(k). The device falls under product code OWI, Bone Fixation Cerclage, Sublaminar, regulated at 21 CFR 888.3010 as a Class 2 device. The review panel was Orthopedic.

FDA logged the submission as received on Apr 27, 2026. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Medicrea International S.A.S in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261374?

K261374 is the FDA 510(k) for LigaPASS System, submitted by Medicrea International S.A.S. FDA's decision date was May 27, 2026, under product code OWI (Bone Fixation Cerclage, Sublaminar).

Who makes the LigaPASS System?

Medicrea International S.A.S, based in Rillieux-La-Pape, is the applicant of record for K261374.

How long did the K261374 review take?

FDA received the submission on Apr 27, 2026 and issued its decision on May 27, 2026, 30 days later.

← All decisions in May 2026