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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 / April 2026 / K260397

510(k) cleared

SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)

Hironic Co., Ltd. · Apr 6, 2026 · K260397

FDA cleared the SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002) from Hironic Co., Ltd. on Apr 6, 2026 under K260397, 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 Feb 6, 2026. The decision came 59 days later, inside the 90 FDA-day goal for a 510(k).

Hironic Co., Ltd. has one other decision in the tracker over the last 12 months: K251334 (NEW DOUBLO 2.0).

Questions & Answers

What did FDA clear under K260397?

K260397 is the FDA 510(k) for SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002), submitted by Hironic Co., Ltd.. FDA's decision date was Apr 6, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the SYNERJET PRO (SP-1002); InPhiuse (SP-1002); WOWJET (SP-1002)?

Hironic Co., Ltd., based in Yongin-Si, is the applicant of record for K260397.

How long did the K260397 review take?

FDA received the submission on Feb 6, 2026 and issued its decision on Apr 6, 2026, 59 days later.

← All decisions in April 2026

Sources