510(k) K031623

MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES by Coalescent Surgical — Product Code FZP

K031623 is an FDA 510(k) premarket notification submitted by Coalescent Surgical for the device "MODIFICATION TO COALESCENT SURGICAL U-CLIP AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on July 3, 2003. The device falls under product code FZP (Clip, Implantable), a Class II device regulated under 21 CFR 878.4300. Coalescent Surgical has at least 8 other 510(k) clearances on record.