510(k) K110958

VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH by Smith & Nephew, Inc. — Product Code FQH

K110958 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "VERSAJET II HYDROSURGERY SYSTEM CONSOLE / EXACT HANDPIECES / PLUS HANDPIECES, VERSAJET FOOTSWITCH". The FDA issued a decision of Substantially Equivalent on August 1, 2011. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Smith & Nephew, Inc. has at least 10 other 510(k) clearances on record.