510(k) K221016

Steriking Packaging for Medical Devices by Wipak OY — Product Code FRG

K221016 is an FDA 510(k) premarket notification submitted by Wipak OY for the device "Steriking Packaging for Medical Devices". The FDA issued a decision of Substantially Equivalent on May 5, 2022. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Wipak OY has at least 6 other 510(k) clearances on record.