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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 / September 2025 / K250128

510(k) cleared

Single Use Suction-Evacuation Ureteral Access Sheath

Anhui Happiness Workshop Medical Instruments Co., Ltd. · Sep 19, 2025 · K250128

FDA cleared the Single Use Suction-Evacuation Ureteral Access Sheath from Anhui Happiness Workshop Medical Instruments Co., Ltd. on Sep 19, 2025 under K250128, a traditional 510(k). The device falls under product code FED, Endoscopic Access Overtube, Gastroenterology-Urology, regulated at 21 CFR 876.1500 as a Class 2 device. The review panel was Gastroenterology, Urology.

FDA logged the submission as received on Jan 17, 2025. The decision came 245 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Anhui Happiness Workshop Medical Instruments Co., Ltd. has one other decision in the tracker over the last 12 months: K252929 (Single Use Digital Flexible Ureteroscope (7.5F); Videoscope Imaging Processor (Model HV-200)).

Questions & Answers

What did FDA clear under K250128?

K250128 is the FDA 510(k) for Single Use Suction-Evacuation Ureteral Access Sheath, submitted by Anhui Happiness Workshop Medical Instruments Co., Ltd.. FDA's decision date was Sep 19, 2025, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the Single Use Suction-Evacuation Ureteral Access Sheath?

Anhui Happiness Workshop Medical Instruments Co., Ltd., based in Bengbu, is the applicant of record for K250128.

How long did the K250128 review take?

FDA received the submission on Jan 17, 2025 and issued its decision on Sep 19, 2025, 245 days later.

← All decisions in September 2025

Sources