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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 / K260521

510(k) cleared

ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)

Zhuhai Pusen Medical Technology Co., Ltd. · Apr 6, 2026 · K260521

FDA cleared the ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250) from Zhuhai Pusen Medical Technology Co., Ltd. on Apr 6, 2026 under K260521, 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 Feb 17, 2026. The decision came 48 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K260521?

K260521 is the FDA 510(k) for ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250), submitted by Zhuhai Pusen Medical Technology Co., Ltd.. FDA's decision date was Apr 6, 2026, under product code FED (Endoscopic Access Overtube, Gastroenterology-Urology).

Who makes the ClearEVAC Ureteral Aspirating Access Sheath (PUS-100-1040,PUS-100-1050, PUS-100-1240,PUS-100-1250)?

Zhuhai Pusen Medical Technology Co., Ltd., based in Zhuhai, is the applicant of record for K260521.

How long did the K260521 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Apr 6, 2026, 48 days later.

← All decisions in April 2026