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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 / June 2026 / K251492

510(k) cleared

Irrigation Tubing Bipolar Cord Set

New Deantronics Taiwan , Ltd. · Jun 29, 2026 · K251492

FDA cleared the Irrigation Tubing Bipolar Cord Set from New Deantronics Taiwan , Ltd. on Jun 29, 2026 under K251492, 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 May 15, 2025. The decision came 410 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

New Deantronics Taiwan , Ltd. has one other decision in the tracker over the last 12 months: K251899 (E Blator).

Questions & Answers

What did FDA clear under K251492?

K251492 is the FDA 510(k) for Irrigation Tubing Bipolar Cord Set, submitted by New Deantronics Taiwan , Ltd.. FDA's decision date was Jun 29, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Irrigation Tubing Bipolar Cord Set?

New Deantronics Taiwan , Ltd., based in New Taipei City, is the applicant of record for K251492.

How long did the K251492 review take?

FDA received the submission on May 15, 2025 and issued its decision on Jun 29, 2026, 410 days later.

← All decisions in June 2026

Sources