510(k) K913114

TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT by Gerard Medical Enterprises, Inc. — Product Code FMF

K913114 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT". The FDA issued a decision of Substantially Equivalent (kit) on January 2, 1992. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Gerard Medical Enterprises, Inc. has at least 7 other 510(k) clearances on record.