510(k) K251177

Self-Seal Sterilization Pouch and Roll by Guangdong Maidi Medical Co., Ltd. — Product Code FRG

K251177 is an FDA 510(k) premarket notification submitted by Guangdong Maidi Medical Co., Ltd. for the device "Self-Seal Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on December 12, 2025. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850.