510(k) K252759

revyve® Antimicrobial Skin and Wound Cleanser by Kane Biotech, Inc. — Product Code FRO

K252759 is an FDA 510(k) premarket notification submitted by Kane Biotech, Inc. for the device "revyve® Antimicrobial Skin and Wound Cleanser". The FDA issued a decision of Substantially Equivalent on January 8, 2026. The device falls under product code FRO (Dressing, Wound, Drug), a Class U device. Kane Biotech, Inc. has at least 2 other 510(k) clearances on record.