510(k) K091441

SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET by Synergetics, Inc. — Product Code FRN

K091441 is an FDA 510(k) premarket notification submitted by Synergetics, Inc. for the device "SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET". The FDA issued a decision of Substantially Equivalent on October 30, 2009. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Synergetics, Inc. has at least 10 other 510(k) clearances on record.