510(k) K011612

MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM by Hydrocision, Inc. — Product Code FQH

K011612 is an FDA 510(k) premarket notification submitted by Hydrocision, Inc. for the device "MODIFICATION TO HYDROCISION DEBRIDEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 22, 2001. 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.