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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 / January 2026 / K251996

510(k) cleared

ENTire IRE System

Entire Medical , Ltd. · Jan 14, 2026 · K251996

FDA cleared the ENTire IRE System from Entire Medical , Ltd. on Jan 14, 2026 under K251996, a traditional 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 Jun 27, 2025. The decision came 201 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Entire Medical , Ltd. has one other decision in the tracker over the last 12 months: K261202 (ENTire IRE System).

Questions & Answers

What did FDA clear under K251996?

K251996 is the FDA 510(k) for ENTire IRE System, submitted by Entire Medical , Ltd.. FDA's decision date was Jan 14, 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 K251996.

How long did the K251996 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Jan 14, 2026, 201 days later.

← All decisions in January 2026

Sources