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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 / November 2025 / K252260

510(k) cleared

RELIEEV HSG Catheter (HSG7FA1)

Li Medical Corporation , Ltd. · Nov 26, 2025 · K252260

FDA cleared the RELIEEV HSG Catheter (HSG7FA1) from Li Medical Corporation , Ltd. on Nov 26, 2025 under K252260, a traditional 510(k). The device falls under product code LKF, Cannula, Manipulator/Injector, Uterine, regulated at 21 CFR 884.4530 as a Class 2 device. The review panel was Obstetrics/Gynecology.

FDA logged the submission as received on Jul 21, 2025. The decision came 128 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Li Medical Corporation , Ltd. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K252260?

K252260 is the FDA 510(k) for RELIEEV HSG Catheter (HSG7FA1), submitted by Li Medical Corporation , Ltd.. FDA's decision date was Nov 26, 2025, under product code LKF (Cannula, Manipulator/Injector, Uterine).

Who makes the RELIEEV HSG Catheter (HSG7FA1)?

Li Medical Corporation , Ltd., based in Xizhi Dist., is the applicant of record for K252260.

How long did the K252260 review take?

FDA received the submission on Jul 21, 2025 and issued its decision on Nov 26, 2025, 128 days later.

← All decisions in November 2025