510(k) K202462

SIGMA Sterilization Pouch and Roll by Sigma Medical Supplies Corporation — Product Code FRG

K202462 is an FDA 510(k) premarket notification submitted by Sigma Medical Supplies Corporation for the device "SIGMA Sterilization Pouch and Roll". The FDA issued a decision of Substantially Equivalent on Apr 23, 2021. The device falls under product code FRG (Wrap, Sterilization), a Class II device regulated under 21 CFR 880.6850. Sigma Medical Supplies Corporation has 1 other 510(k) clearance on record.