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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 / May 2026 / K254050

510(k) cleared

Manual Tissue Removal Device

Suzhou AcuVu Medical Technology Co., Ltd. · May 15, 2026 · K254050

FDA cleared the Manual Tissue Removal Device from Suzhou AcuVu Medical Technology Co., Ltd. on May 15, 2026 under K254050, a traditional 510(k). The device falls under product code HIH, Hysteroscope (And Accessories), regulated at 21 CFR 884.1690 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Dec 17, 2025. The decision came 149 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Suzhou AcuVu Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254050?

K254050 is the FDA 510(k) for Manual Tissue Removal Device, submitted by Suzhou AcuVu Medical Technology Co., Ltd.. FDA's decision date was May 15, 2026, under product code HIH (Hysteroscope (And Accessories)).

Who makes the Manual Tissue Removal Device?

Suzhou AcuVu Medical Technology Co., Ltd., based in Suzhou, Jiangsu, is the applicant of record for K254050.

How long did the K254050 review take?

FDA received the submission on Dec 17, 2025 and issued its decision on May 15, 2026, 149 days later.

← All decisions in May 2026