510(k) K223025

Tyvek Roll with CI for STERLINK Sterilizer by Plasmapp Co,., Ltd. — Product Code FRG

K223025 is an FDA 510(k) premarket notification submitted by Plasmapp Co,., Ltd. for the device "Tyvek Roll with CI for STERLINK Sterilizer". The FDA issued a decision of Substantially Equivalent on May 9, 2023. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Plasmapp Co,., Ltd. has at least 7 other 510(k) clearances on record.