510(k) K143115

The VersaJet II Hydrosurgery System by Smith & Nephew, Inc. — Product Code FQH

K143115 is an FDA 510(k) premarket notification submitted by Smith & Nephew, Inc. for the device "The VersaJet II Hydrosurgery System". The FDA issued a decision of Substantially Equivalent on July 15, 2015. 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.