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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 / K260380

510(k) cleared

Mendit

Escala Medical, Ltd. · Mar 4, 2026 · K260380

FDA cleared the Mendit from Escala Medical, Ltd. on Mar 4, 2026 under K260380, a special 510(k). The device falls under product code PBQ, Fixation, Non-Absorbable Or Absorbable, For Pelvic Use, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Feb 5, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Escala Medical, Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260380?

K260380 is the FDA 510(k) for Mendit, submitted by Escala Medical, Ltd.. FDA's decision date was Mar 4, 2026, under product code PBQ (Fixation, Non-Absorbable Or Absorbable, For Pelvic Use).

Who makes the Mendit?

Escala Medical, Ltd., based in Misgav, is the applicant of record for K260380.

How long did the K260380 review take?

FDA received the submission on Feb 5, 2026 and issued its decision on Mar 4, 2026, 27 days later.

← All decisions in March 2026