510(k) K021813

HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM by Hydrocision, Inc. — Product Code FQH

K021813 is an FDA 510(k) premarket notification submitted by Hydrocision, Inc. for the device "HYDROCISION GENERAL SURGERY FLUIDJET SYSTEM". The FDA issued a decision of Substantially Equivalent on May 9, 2003. The device falls under product code FQH (Lavage, Jet), a Class II device regulated under 21 CFR 880.5475. Hydrocision, Inc. has at least 10 other 510(k) clearances on record.