510(k) K213758

Lexa PLUS RIS-311 by W&H Sterilization S.R.L. — Product Code FLE

K213758 is an FDA 510(k) premarket notification submitted by W&H Sterilization S.R.L. for the device "Lexa PLUS RIS-311". The FDA issued a decision of Substantially Equivalent on August 19, 2022. The device falls under product code FLE (Sterilizer, Steam), a Class II device regulated under 21 CFR 880.6880. W&H Sterilization S.R.L. has at least 3 other 510(k) clearances on record.