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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 / K260466

510(k) cleared

Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)

Zhejiang shuyou Surgical Instrument Co., Ltd. · Apr 7, 2026 · K260466

FDA cleared the Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode) from Zhejiang shuyou Surgical Instrument Co., Ltd. on Apr 7, 2026 under K260466, 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 12, 2026. The decision came 54 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Zhejiang shuyou Surgical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260466?

K260466 is the FDA 510(k) for Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode), submitted by Zhejiang shuyou Surgical Instrument Co., Ltd.. FDA's decision date was Apr 7, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Multifunctional Operational Dissectors (Electrosurgical Pencils);Multifunctional Operational Dissectors (Disposable Electrode)?

Zhejiang shuyou Surgical Instrument Co., Ltd., based in Huzhou, is the applicant of record for K260466.

How long did the K260466 review take?

FDA received the submission on Feb 12, 2026 and issued its decision on Apr 7, 2026, 54 days later.

← All decisions in April 2026