510(k) K202222

Irrisept Wound Debridement and Cleansing System by Irrimax Corporation — Product Code FQH

K202222 is an FDA 510(k) premarket notification submitted by Irrimax Corporation for the device "Irrisept Wound Debridement and Cleansing System". The FDA issued a decision of Substantially Equivalent on December 14, 2020. 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.