510(k) K232625

Steriking® Pouch for Robotic Instruments by Wipak OY — Product Code FRG

K232625 is an FDA 510(k) premarket notification submitted by Wipak OY for the device "Steriking® Pouch for Robotic Instruments". The FDA issued a decision of Substantially Equivalent on June 7, 2024. 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.