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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 / K251177

510(k) cleared

Self-Seal Sterilization Pouch and Roll

Guangdong Maidi Medical Co., Ltd. · Dec 12, 2025 · K251177

FDA cleared the Self-Seal Sterilization Pouch and Roll from Guangdong Maidi Medical Co., Ltd. on Dec 12, 2025 under K251177, a traditional 510(k). The device falls under product code FRG, Wrap, Sterilization, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Apr 16, 2025. The decision came 240 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 Guangdong Maidi Medical Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251177?

K251177 is the FDA 510(k) for Self-Seal Sterilization Pouch and Roll, submitted by Guangdong Maidi Medical Co., Ltd.. FDA's decision date was Dec 12, 2025, under product code FRG (Wrap, Sterilization).

Who makes the Self-Seal Sterilization Pouch and Roll?

Guangdong Maidi Medical Co., Ltd., based in Guangdong, is the applicant of record for K251177.

How long did the K251177 review take?

FDA received the submission on Apr 16, 2025 and issued its decision on Dec 12, 2025, 240 days later.

← All decisions in December 2025