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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 / K261202

510(k) cleared

ENTire IRE System

Entire Medical , Ltd. · May 29, 2026 · K261202

FDA cleared the ENTire IRE System from Entire Medical , Ltd. on May 29, 2026 under K261202, a special 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Apr 13, 2026. The decision came 46 days later, inside the 90 FDA-day goal for a 510(k).

Entire Medical , Ltd. has one other decision in the tracker over the last 12 months: K251996 (ENTire IRE System).

Questions & Answers

What did FDA clear under K261202?

K261202 is the FDA 510(k) for ENTire IRE System, submitted by Entire Medical , Ltd.. FDA's decision date was May 29, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the ENTire IRE System?

Entire Medical , Ltd., based in Herzeliya, is the applicant of record for K261202.

How long did the K261202 review take?

FDA received the submission on Apr 13, 2026 and issued its decision on May 29, 2026, 46 days later.

← All decisions in May 2026

Sources