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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 / December 2025 / K253222

510(k) cleared

Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

Zhejiang Gongdong Medical Technology Co., Ltd. · Dec 22, 2025 · K253222

FDA cleared the Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) from Zhejiang Gongdong Medical Technology Co., Ltd. on Dec 22, 2025 under K253222, a traditional 510(k). The device falls under product code MMK, Container, Sharps, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Sep 29, 2025. The decision came 84 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253222?

K253222 is the FDA 510(k) for Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G), submitted by Zhejiang Gongdong Medical Technology Co., Ltd.. FDA's decision date was Dec 22, 2025, under product code MMK (Container, Sharps).

Who makes the Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)?

Zhejiang Gongdong Medical Technology Co., Ltd., based in Taizhou, is the applicant of record for K253222.

How long did the K253222 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Dec 22, 2025, 84 days later.

← All decisions in December 2025