510(k) K210536

Irrisept Antimicrobial Wound Lavage by Irrimax Corporation — Product Code FQH

K210536 is an FDA 510(k) premarket notification submitted by Irrimax Corporation for the device "Irrisept Antimicrobial Wound Lavage". The FDA issued a decision of Substantially Equivalent on May 28, 2021. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Irrimax Corporation has at least 4 other 510(k) clearances on record.