510(k) K220964

VERSAJET Hydrosurgery System (III) by Smith & Nephew Medical Limited — Product Code FQH

K220964 is an FDA 510(k) premarket notification submitted by Smith & Nephew Medical Limited for the device "VERSAJET Hydrosurgery System (III)". The FDA issued a decision of Substantially Equivalent on May 16, 2023. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Smith & Nephew Medical Limited has at least 10 other 510(k) clearances on record.