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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 / September 2025 / K251334

510(k) cleared

NEW DOUBLO 2.0

Hironic Co., Ltd. · Sep 29, 2025 · K251334

FDA cleared the NEW DOUBLO 2.0 from Hironic Co., Ltd. on Sep 29, 2025 under K251334, 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 Apr 30, 2025. The decision came 152 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Hironic Co., Ltd. has one other decision in the tracker over the last 12 months: K260397 (SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)).

Questions & Answers

What did FDA clear under K251334?

K251334 is the FDA 510(k) for NEW DOUBLO 2.0, submitted by Hironic Co., Ltd.. FDA's decision date was Sep 29, 2025, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the NEW DOUBLO 2.0?

Hironic Co., Ltd., based in Yongin-Si, is the applicant of record for K251334.

How long did the K251334 review take?

FDA received the submission on Apr 30, 2025 and issued its decision on Sep 29, 2025, 152 days later.

← All decisions in September 2025

Sources