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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 / October 2025 / K251882

510(k) cleared

Uterine Aspiration Set

Gcmedica Enterprise Ltd.(Wuxi) · Oct 16, 2025 · K251882

FDA cleared the Uterine Aspiration Set from Gcmedica Enterprise Ltd.(Wuxi) on Oct 16, 2025 under K251882, a traditional 510(k). The device falls under product code HHK, Curette, Suction, Endometrial (And Accessories), regulated at 21 CFR 884.1175 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jun 20, 2025. The decision came 118 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 Gcmedica Enterprise Ltd.(Wuxi) in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251882?

K251882 is the FDA 510(k) for Uterine Aspiration Set, submitted by Gcmedica Enterprise Ltd.(Wuxi). FDA's decision date was Oct 16, 2025, under product code HHK (Curette, Suction, Endometrial (And Accessories)).

Who makes the Uterine Aspiration Set?

Gcmedica Enterprise Ltd.(Wuxi), based in Wuxi, is the applicant of record for K251882.

How long did the K251882 review take?

FDA received the submission on Jun 20, 2025 and issued its decision on Oct 16, 2025, 118 days later.

← All decisions in October 2025